Thrombosis Research Institute Garfield AF Paper CRF · 2017-01-07 · Thrombosis Research Institute...
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Thrombosis Research Institute Garfield AF Paper CRF Amendment 4 v1.2 Version: 5.2 Date: 7 January 2015
Transcript of Thrombosis Research Institute Garfield AF Paper CRF · 2017-01-07 · Thrombosis Research Institute...
Thrombosis Research Institute
Garfield AF Paper CRFAmendment 4 v1.2
Version: 5.2
Date: 7 January 2015
Thrombosis Research Institute
Version 5.2 Page 1 of 42
Garfield AF ................................................................................................................................................................................................... 3
Inclusion & Exclusion Criteria...................................................................................................................................................................................... 3
Demographics (at diagnosis)....................................................................................................................................................................................... 3
Atrial Fibrillation Diagnosis......................................................................................................................................................................................... 5
Treatment at Diagnosis - Treatment............................................................................................................................................................................ 6
Treatment at Diagnosis - Stroke Prophylaxis ............................................................................................................................................................... 8
Cardiovascular History.............................................................................................................................................................................................. 15
Additional Medical History ....................................................................................................................................................................................... 17
Event Summary........................................................................................................................................................................................................ 17
AF Treatment Change............................................................................................................................................................................................... 19
Stroke Prophylaxis ................................................................................................................................................................................................... 20
Stroke/TIA ............................................................................................................................................................................................................... 26
Peripheral Embolism ................................................................................................................................................................................................ 27
Cardiovascular Update ............................................................................................................................................................................................. 28
Additional Medical History Update ........................................................................................................................................................................... 29
Myocardial Infarction/Acute Coronary Syndrome ..................................................................................................................................................... 30
Hospitalisation/Procedure/Consultation................................................................................................................................................................... 31
Bleeding Event ......................................................................................................................................................................................................... 34
Death....................................................................................................................................................................................................................... 36
Follow-up................................................................................................................................................................................................................. 37
Cardioversion........................................................................................................................................................................................................... 38
INR Testing............................................................................................................................................................................................................... 38
INR Results............................................................................................................................................................................................................... 39
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Extension Consent (Patient Summary Page) .............................................................................................................................................................. 39
Event Summary Extension ........................................................................................................................................................................................ 39
Follow-up Extension................................................................................................................................................................................................. 42
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Garfield AF
Inclusion & Exclusion Criteria
Date of assessment
Age at assessment years
Country
Which cohort is this case selected for
Date atrial fibrillation diagnosed
Duration of AF month(s)
Date consent form signed
Dropdown values:
Which cohort is this case selected for - Retrospective
Prospective
Does the patient have an additional risk factor for stroke No Yes Unknown
Does the AF have a reversible cause No Yes Unknown
Will it be possible to follow-up the patient No Yes Unknown
Demographics (at diagnosis)
Sex Male Female
Date of birth
Race/Ethnicity
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Dropdown values:
Race/Ethnicity - Caucasian
Hispanic / Latino
Afro-Caribbean
Asian
Chinese
Mixed
Patient unwilling to declare
Unknown
Other
Height status Measured Not measured/unknown
Height cm
Height feet
Height inches
Height autocalculated in meters
Weight status Measured Not measured/unknown
Weight kg
Weight lbs
Weight autocalculated in kilograms
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Blood pressure (representative blood pressure during admission or at the
time of consultation)
Measured Not measured/unknown
Systolic blood pressure mmHg
Diastolic blood pressure mmHg
Pulse status Measured Not measured/unknown
Pulse bpm
Atrial Fibrillation Diagnosis
Symptoms of AF None Chest pain /discomfort
Dizziness
Fainting Irregular pulse Palpitations
Shortness of breath Sweating Tiredness
Tachycardia Other
Type of atrial fibrillation Permanent Persistent Paroxysmal
New
Investigations used to diagnose AF Unknown ECG Holter
Stress test Echocardiography Other
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ECG Morphology Unknown Right BundleBranch Block
Left Bundle BranchBlock
First degree AVBlock
Second degree AVBlock
Third degree AVBlock
LV hypertrophy Significant Q Wave Normal
Other
Left Ventricular Ejection Fraction measured No Yes Measured butresult unknown
Left Ventricular Ejection Fraction %
Treatment at Diagnosis - Treatment
Care setting at diagnosis/Speciality Internal medicine Cardiology Neurology
Geriatrics Primary care /general practice
Care setting at diagnosis/Location Hospital Office Anticoagulationclinic/thrombosiscentre
Emergency room
Is the patient treated In the public sector In the privatesector
Unknown
Are the costs of the patient's AF treatment covered by Public insurance Private (insurance) Private (out ofpocket)
Combination of theabove
Unknown
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Atrial fibrillation treatment strategy initiated Rhythm Rate Both
Unknown None
Cardioversion No Yes Unknown
AF drug therapy None Class Ia Class Ic
Class II (BetaBlocker)
Class III Class IV (CalciumChannel Blocker)
Digoxin/OtherDigitalis
Prior cardiac medication (present at AF diagnosis) None Statin Ace inhibitor
Angiotensinreceptor blocker (ARB)
NSAID includingCox-2-inhibitors
ASA
Aldosteroneblockade
Loop or otherdiuretic
Nitrates
Hormonereplacement therapy
Proton pumpinhibitors
Anti-retroviralagents
Erythropoetinstimulating agents
ADP receptor/P2Y12 inhibitors
Antimycotics
Oral antidiabeticdrugs
Insulin VKAs
Alpha blockers Class Ia Class Ic
Class III Class IV (CalciumChannel Blocker)
Digoxin and otherDigitalis
Class II (Beta-Blockers)
Unknown
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Continuing/new cardiac medication (continued after AF diagnosis) None Statin ACE inhibitor
Angiotensinreceptor blocker (ARB)
NSAID includingCox-2-inhibitors
ASA
Aldosteroneblockade
Loop or otherdiuretic
Nitrates
Hormonereplacement therapy
Proton pumpinhibitors
Anti-retroviralagents
Erythropoetinstimulating agents
ADP receptor/P2Y12 inhibitors
Antimycotics
Oral antidiabeticdrugs
Insulin VKAs
Alpha blockers Class Ia Class Ic
Class III Class IV (CalciumChannel Blocker)
Digoxin and otherDigitalis
Class II (Beta-Blockers)
Unknown
Treatment at Diagnosis - Stroke Prophylaxis
Anti-platelet drugs None Other COX inhibitor ADPreceptor/P2Y12inhibitors
Prostaglandinanalogues (PG12)
Aspirin/ASA Other
Other COX inhibitor
treatment period
Ongoing Start date Termination date
Reason for end of treatment
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Other COX inhibitor
treatment interruption
No Yes Start date of
interruption
End date of
interruption
Other COX inhibitor medication Acetylsalicylic acid(Aspirin/ASA)
Other
Reason for treatment interruption
ADP receptor/P2Y12
inhibitors treatment
period
Ongoing Start date Termination date
Reason for end of treatment
ADP receptor/P2Y12
inhibitors treatment
interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
ADP receptor/P2Y12 inhibitors medication Ticagrelor Clopidogrel Prasugrel
Other
Prostaglandin
analogues (PG12)
treatment period
Ongoing Start date Termination date
Reason for end of treatment
Prostaglandin
analogues (PG12)
treatment interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
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Anticoagulant drugs None Vitamin Kantagonists
Heparinoid
Heparins Injectable factor Xainhibitors
Oral factor Xainhibitors
Injectable directthrombin inhibitors
Oral directthrombin inhibitors
Other
Will patient complete ACTS (Anti-Clot Treatment Scale) Questionnaire? No Yes
Main reason anticoagulant not used
VKA compliance concern Dementia Low patientmotivation
Limited access toINR monitoring
Other
Reason patient refused to take VKA Bleeding risk INR monitoring Food restriction
Low stroke risk Other
VKA medication
Vitamin K antagonists
treatment period
Ongoing Start date Termination date
Reason for end of treatment
Vitamin K antagonists
treatment interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Heparinoid treatment
period
Ongoing Start date Termination date
Reason for end of treatment
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Heparinoid treatment
interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Heparins treatment
period
Ongoing Start date Termination date
Reason for end of treatment
Heparins treatment
interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Dose frequency for Oral factor Xa inhibitors Once daily Twice daily Other dosingregimen
Oral factor Xa
inhibitors treatment
period
Ongoing Start date Termination date
Reason for end of treatment
Oral factor Xa
inhibitors treatment
interruption
No Yes Start date of
interruption
End date of
interruption
Oral factor Xa inhibitors medication Rivaroxaban Apixaban Edoxaban
Other
Reason for treatment interruption
Injectable factor Xa
inhibitors treatment
period
Ongoing Start date Termination date
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Reason for end of treatment
Injectable factor Xa
inhibitors treatment
interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Injectable direct
thrombin inhibitors
treatment period
Ongoing Start date Termination date
Reason for end of treatment
Injectable direct
thrombin inhibitors
treatment interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Dose frequency for Oral direct thrombin inhibitors Once daily Twice daily Other dosingregimen
Oral direct thrombin
inhibitors treatment
period
Ongoing Start date Termination date
Reason for end of treatment
Oral direct thrombin
inhibitors treatment
interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Oral direct thrombin inhibitors medication Dabigatran Other
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Thrombolytic/Fibrinolytic drugs None Plasminogenactivators
Other serineendopeptidases
Non medicinal No Yes Unknown
Dropdown values:
Reason for end of treatment - Patient decision
Physicians decision
Cost and reimbursement issue
Pregnancy or adverse events
End of planned treatment
Switch to other anti-coagulant
Other
Reason for treatment interruption - Patient decision
Physician decision
Procedure or surgery
Adverse events
Other
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Main reason anticoagulant not used - Unknown
Pregnancy
Previous bleeding event
Alcohol abuse
Taking medication contra-indicated or cautioned for use with VKAs
Taking medication contra-indicated or cautioned for use withanticoagulants
Already taking anti-platelet drugs for other medical condition
Patient refusal to take VKA
Patient refusal to take anticoagulants
VKA compliance concern
Anticoagulant compliance concern
Bleeding risk
Low stroke risk
Guideline recommendation
Fall risk
Other reason
VKA medication - Warfarin
Phenprocoumon
Acenocoumarol
Other
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Cardiovascular History
History of cardiac condition Normal Congenital cardiacanomaly
Congestive cardiacfailure
Coronary arterydisease
Dilatedcardiomyopathy /Severe LV impairment
Intracardiacthrombosis
Valve disease Other Other structuralcardiac disease
Current cardiac condition Normal Congenital cardiacanomaly
Congestive cardiacfailure
Coronary arterydisease
Dilatedcardiomyopathy /Severe LV impairment
Intracardiacthrombosis
Valve disease Other Other structuralcardiac disease
Valvular Disease Aortic Stenosis AorticRegurgitation
MitralRegurgitation
Other
Congenital cardiac anomaly Corrected Uncorrected
Congestive heart failure NYHA Class I NYHA Class II NYHA Class III
NYHA Class IV Unknown
Known chronic angina Pectoris No Yes Unknown
Current MI or Unstable angina No Yes Unknown
History of MI or unstable angina No Yes Unknown
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Family history of cardiac disease No Atrial Fibrillation Prematureischaemic heartdisease
Other Unknown
History of aortic or peripheral artery disease No Yes Unknown
Correction of Artery disease Uncorrected Corrected Unknown
History of carotid disease No Yes Unknown
Correction of Carotid disease Uncorrected Corrected Unknown
Pulmonary Embolism or Deep Vein Thrombosis No Yes Unknown
Systemic embolization No Yes Unknown
Previous endarterectomies No Yes Unknown
Stenting No Yes Unknown
Type of stent Unknown Bare metalcoronary stent
Drug elutingcoronary stent
Carotid stent Bioabsorbable stent
Coronary artery bypass graft No Yes Unknown
Pacemaker No Yes Unknown
Prior transient ischaemic attack No Yes Unknown
Prior stroke No Yes Unknown
History of bleeding No Yes Unknown
Sleep Apnea No Yes Unknown
Correction of Sleep apnea Uncorrected Corrected Unknown
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Patient tested for Chagas disease No Yes Unknown
Positive serology No Yes Unknown
Additional Medical History
Hypertension No Yes Unknown
Hypercholesterolaemia No Yes Unknown
Diabetes No Type I Type II
Alcohol consumption Abstinent Light Moderate
Heavy Unknown
Smoker No Ex smoker Current smoker
Unknown
Cirrhosis No Yes Unknown
Chronic renal disease None I II
III IV V
Unknown
Dementia No Yes Unknown
Hyperthyroidism No Yes Unknown
Hypothyroidism No Yes Unknown
Event Summary
Date of event
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Event being entered Rhythm/Vital signs Treatmentchange/interruption
Stroke/TIA
Cardioversion Bleed Cardiovascular/Medical history update
Peripheralembolism (non CNS)
Death MyocardialInfarction/AcuteCoronary Syndrome
Lost to follow up Hospitalization/Procedure/Consultation
Patient withdrewconsent
Is the patient treated In the public sector In the privatesector
Unknown
Are the costs of the patient's AF treatment covered by Public insurance Private (insurance) Private (out ofpocket)
Combination of theabove
Unknown
Rhythm status Measured Not measured/unknown
Rhythm Atrial Fibrillation Atrial Flutter Sinus Rhythm
Other
Type of atrial fibrillation Permanent Persistent Paroxysmal
Unknown
Weight status Measured Not measured/unknown
Weight kg
Weight lbs
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Blood pressure (representative blood pressure during admission or at the
time of consultation)
Measured Not measured/unknown
Systolic blood pressure mmHg
Diastolic blood pressure mmHg
Pulse status Measured Not measured/unknown
Pulse beats per minute
Reason for lost to follow up
Dropdown values:
Reason for lost to follow up - Patient enrolled in a Clinical Trial
Patient moved to another location
Patient will be treated by another physician
Patient cannot be contacted
Clinical decision
Unknown
Other
AF Treatment Change
Date of Treatment change/interruption
Atrial fibrillation treatment strategy initiated Rhythm Rate Both
None Unknown
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AF drug therapy None Class 1a Class 1c
Class II (BetaBlocker)
Class III Class IV (CalciumChannel Blocker)
Digoxin/OtherDigitalis
Other cardiac medication/co-medication None Statin ACE inhibitor
Angiotensinreceptor blocker (ARB)
NSAID includingCox-2-inhibitors
ASA
Aldosteroneblockade
Loop or otherdiuretic
Nitrates
Hormonereplacement therapy
Proton pumpinhibitors
Anti-retroviralagents
Erythropoetinstimulating agents
ADP receptor/P2Y12 inhibitors
Antimycotics
Oral antidiabeticdrugs
Insulin VKAs
Alpha blockers Class Ia Class Ic
Class III Ca channel blockers Digoxin and otherDigitalis
Betablockers Unknown
Stroke Prophylaxis
Date of Treatment change/interruption
Anti-thrombotic medication No Yes Unknown
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Antiplatelet drugs None Other COX inhibitor ADPreceptor/P2Y12inhibitors
Prostaglandinanalogues (PG12)
Aspirin/ASA Other
ADP receptor/P2Y12
inhibitors treatment
period
Ongoing Start date Termination date
Reason for end of treatment
ADP receptor/P2Y12
inhibitors treatment
interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
ADP receptor / P2Y12 inhibitors medication Ticagrelor Clopidogrel Prasugrel
Other
Prostaglandin
analogues (PG12)
treatment period
Ongoing Start date Termination date
Reason for end of treatment
Prostaglandin
analogues (PG12)
treatment interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Other COX inhibitor
treatment period
Ongoing Start date Termination date
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Reason for end of treatment
Other COX inhibitor
treatment interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Other COX inhibitor medication Acetylsalicylic acid(Aspirin/ASA)
Other
Anticoagulant drugs None Vitamin Kantagonists
Heparinoid
Heparins Injectable factor Xainhibitors
Oral factor Xainhibitors
Injectable directthrombin inhibitors
Oral directthrombin inhibitors
Other
Unknown
Will patient complete ACTS (Anti-Clot Treatment Scale) Questionnaire? No Yes
Vitamin K antagonists
treatment period
Ongoing Start date Termination date
Reason for end of treatment
Vitamin K antagonists
treatment interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
VKA medication
Heparinoid treatment
period
Ongoing Start date Termination date
Reason for end of treatment
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Heparinoid treatment
interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Heparins treatment
period
Ongoing Start date Termination date
Reason for end of treatment
Heparins treatment
interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Injectable factor Xa
inhibitors treatment
period
Ongoing Start date Termination date
Reason for end of treatment
Injectable factor Xa
inhibitors treatment
interruption
No Yes Start date interruption End date interruption
Reason for treatment interruption
Oral factor Xa
inhibitors treatment
period
Ongoing Start date Termination date
Reason for end of treatment
Oral factor Xa
inhibitors treatment
interruption
No Yes Start date of
interruption
End date of
interruption
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Reason for treatment interruption
Dose frequency for Oral factor Xa inhibitors Once daily Twice daily Other dosingregimen
Unknown
Oral factor Xa inhibitors medication Rivaroxaban Apixaban Edoxaban
Other
Injectable direct
thrombin inhibitors
treatment period
Ongoing Start date Termination date
Reason for end of treatment
Injectable direct
thrombin inhibitors
treatment interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Oral direct thrombin
inhibitors treatment
period
Ongoing Start date Termination date
Reason for end of treatment
Oral direct thrombin
inhibitors treatment
interruption
No Yes Start date of
interruption
End date of
interruption
Reason for treatment interruption
Dose frequency for Oral direct thrombin inhibitors Once daily Twice daily Other dosingregimen
Unknown
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Oral direct thrombin inhibitors medication Dabigatran Other
Main reason anticoagulant not used
VKA compliance concern Dementia Low patientmotivation
Limited access toINR monitoring
Other Unknown
Reason patient refused to take VKA Bleeding risk INR monitoring Food restriction
Low stroke risk Other Unknown
Thrombolytic/Fibrinolytic drugs None Plasminogenactivators
Other serineendopeptidases
Unknown
Non medicinal No Yes Unknown
Dropdown values:
Reason for end of treatment - Patient decision
Physicians decision
Cost and reimbursement issue
Pregnancy or adverse events
End of planned treatment
Switch to other anti-coagulant
Other
Reason for treatment interruption - Patient decision
Physician decision
Procedure or surgery
Adverse events
Other
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VKA medication - Warfarin
Phenprocoumon
Acenocoumarol
Other
Unknown
Main reason anticoagulant not used - Unknown
Pregnancy
Previous bleeding event
Alcohol abuse
Taking medication contra-indicated or cautioned for use with VKAs
Taking medication contra-indicated or cautioned for use withanticoagulants
Already taking anti-platelet drugs for other medical condition
Patient refusal to take VKA
Patient refusal to take anticoagulants
Bleeding risk
VKA compliance concern
Anticoagulant compliance concern
Fall risk
Low stroke risk
Guideline recommendation
Other reason
Stroke/TIA
Date of Stroke/TIA
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Event type Transient ischaemicattack
Stroke
Has the neurological event resolved No Yes Unknown
Type of Stroke Primary IschemicStroke
Primaryintracerebralhemorrhage
Secondaryhemorrhagic ischemicstroke
Unknown
Primary Ischemic Stroke Cardioembolic Non-Cardioembolic Uncertain
Was there an haemorrhagic conversion No Yes Unknown
Was haemorrhagic conversion symptomatic No Yes Unknown
Primary Intracerebral hemorrhage Intracerebral Subarachnoid Intraventricular
Unknown
Method of Diagnosis NeurologicalConsultation
CT Scan MRI Scan
InvasiveAngiography
Other Unknown
Did neuro-imaging show an ischemic defect matching the clinical symptoms No Yes Not done
Did subject receive thrombolytic therapy for the suspected stroke No Yes Unknown
Narrative (Stroke)
Peripheral Embolism
Date of Peripheral embolism
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Location of embolism Upper limb Lower limb Renal
Mesenteric Splenic Hepatic
Ocular / retinal Other Unknown
Method of Diagnosis Ultrasound Arteriogram CT scan / Ct angio
MRI / MRA Other Unknown
Intervention for embolism None Drug treatment Percutaneousintervention
Surgery Other Unknown
Recent trauma to the affected vessel No Yes Unknown
Recent intervention to the affected vessel No Yes Unknown
Cardiovascular Update
Date of Medical history update
Cardiac condition Normal Congenital cardiacanomaly
Congestive cardiacfailure
Coronary arterydisease
Dilatedcardiomyopathy /Severe LV impairment
Intracardiacthrombosis
Rheumatic heartdisease
Valve disease Other structuralcardiac disease
Other Unknown
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Cardiac condition worsened No Congenital cardiacanomaly
Congestive cardiacfailure
Coronary arterydisease
Dilatedcardiomyopathy /Severe LV impairment
Intracardiacthrombosis
Rheumatic heartdisease
Valve disease Other structuralcardiac disease
Other Unknown
Valvular Disease Aortic Stenosis AorticRegurgitation
MitralRegurgitation
Other Unknown
Congestive heart failure NYHA Class I NYHA Class II NYHA Class III
NYHA Class IV Unknown
Angina Pectoris No Yes Unknown
Aortic or peripheral artery disease No Yes Unknown
Correction of artery disease Uncorrected Corrected Unknown
Carotid disease No Yes Unknown
Correction of carotid disease Uncorrected Corrected Unknown
Additional Medical History Update
Hypertension No Yes Unknown
Hypercholesterolaemia No Yes Unknown
Diabetes No Type I Type II
Unknown
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Alcohol consumption Abstinent Light Moderate
Heavy Unknown
Smoker No Ex smoker Current smoker
Unknown
Cirrhosis No Yes Unknown
Chronic renal disease None I II
III IV V
Unknown
Dementia No Yes Unknown
Hyperthyroidism No Yes Unknown
Hypothyroidism No Yes Unknown
Sleep Apnea No Yes Unknown
Correction of Sleep apnea Uncorrected Corrected Unknown
Patient tested for Chagas disease No Yes Unknown
Positive serology No Yes Unknown
Myocardial Infarction/Acute Coronary Syndrome
Date of Myocardial Infarction/Acute Coronary Syndrome
Type of MI Non-procedural Peri-procedural
Cardiac markers collected No Yes Unknown
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ECG evidence No ECG available No changes Dynamic ST-T wavechanges
New Q waves in atleast two leads
Did the patient receive thrombolysis for the therapy No Yes Unknown
Final diagnosis Unstable angina STEMI Non STEMI
Other Unknown
Hospitalisation/Procedure/Consultation
Date of Hospitalization/Procedure/Consultation
Was there a treatment change/interruption during this
hospitalization/procedure/consultation (including peri-operative therapy)
No Yes Unknown
Was medical contact expected Unexpected Expected
Type of medical contact
Unit location Out patient In patient
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Intervention required No PCI bare metalstent
PCI drug elutingstent
PCI balloonangioplasty
CABG Valve replacement
Pacemaker Carotid stent Implantablecardioverter-defibrillator
Ablation Left AtrialAppendage Procedure
Unknown
None of the above(Other)
Reason for ablation Atrial Fibrillation Other arrhythmia Unknown
Left Atrial Appendage Procedure Open surgical Percutaneous Unknown
Open surgical procedure Amputation Ligation Other
Unknown
Percutaneous procedure Watchmanocclusion
Amplatzerocclusion
Lariat ligation
Other Unknown
Operative priority None Elective Emergency
Unknown
Still in hospital No Yes Unknown
Date of discharge
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Reason(s) for medical contact Pulmonaryembolism
Complication ofVTE
DVT
Non-cardiac Check up of knowncardiac disease
Other
Unknown
Number of days in hospital
Intensive Therapy Unit stay length days
Coronary Care Unit stay length days
Short Stay Unit days days
Days in hospital status Unknown Known
Intensive Care Therapy Unit Stay status Unknown Known
Coronary Care Unit stay status Unknown Known
Short Stay Unit stay status Unknown Known
Dropdown values:
Type of medical contact - Hospital admission
Outpatient hospital attendance
Emergency room
Visit to the family doctor
Stroke unit
Office based specialist
Other
Unknown
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Bleeding Event
Date of Bleeding event
Site of bleed
Severity of bleed Minor Non-majorclinically relevant
Major
Unknown
Bleeding precipitant Spontaneous Trauma-related(non-surgical)
Cardiac surgery
Non-cardiacsurgery
Unknown
Intervention required No Medical Surgical
Unknown
Transfusions required No Yes Unknown
Outcome of bleed Resolved Ongoing Patient died
Unknown
Date bleed resolved
Dropdown values:
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Site of bleed - Intra-spinal
Subconjunctival
Intra-ocular / Retinal
GI Upper
GI Lower
Macroscopic haematuria
Abnormal uterine (metrorraghia)
Menorrhagia
Intra-articular
Intra-muscular (no compartment syndrome)
Intra-muscular (with compartment syndrome)
Epidural Hematoma
Epistaxis
Gingival
Intra-peritoneal
Retroperitoneal
Puncture site
Skin (Ecchymosis other than instrument site)
Hemoptysis
Haemo-pericardium
Haemothorax
Other
Subdural Hematoma
Unknown
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Death
Date of Death
Primary cause of death Cardiovascular Non-cardiovascular Unknown
Cardiovascular cause of death
Non-cardiovascular cause of death
Source of mortality information Family contact Physician contact Death certificate
Hospital charts /notes
Other
Date death form completed
Dropdown values:
Cardiovascular cause of death - Myocardial infarction
Non-haemorrhagic stroke (Ischemic Stroke)
Intracranial/spinal haemorrhage
Atherosclerotic vascular disease
Congestive heart failure
Directly related to revascularisation
Dysrhythmia
Pulmonary embolism
Sudden or unwitnessed death
Haemorrhagic stroke
Other
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Non-cardiovascular cause of death - Accidental / trauma
Respiratory failure
Infection
Malignancy
Suicide
Liver failure
Renal
Sepsis
Other
Follow-up
Date of follow up
Is this record one of the following study milestones Retrospective data 4 months 8 months
12 months 16 months 20 months
24 months
Have all rhythm and vital signs measurements been entered so far No Yes
Have all of the events been entered so far No Yes
No death event was entered in the previous 4 months. Death is a primary
endpoint. Can you confirm that no death occurred in the previous 4
months?
No Yes
No stroke event was entered in the previous 4 months. Stroke is a primary
endpoint. Can you confirm that no stroke occurred in the previous 4
months?
No Yes
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No bleed event was entered in the previous 4 months. Bleed is a primary
endpoint. Can you confirm that no bleed occurred in the previous 4
months?
No Yes
Care setting at follow up/Speciality Internal medicine Cardiology Neurology
Geriatrics Primary care /general practice
Care setting at follow up/Location Hospital Office Anticoagulationclinic/thrombosiscentre
Emergency room
Principal investigator's PIN
Cardioversion
Cardioversion Pharmacologicalcardioversion
Direct currentcardioversion
Successful cardioversion (return to sinus rhythm within 24 hours) No Yes Unknown
Successful cardioversion (patient in sinus rhythm at discharge) No Yes Unknown
INR Testing
INR testing status Patient self testing/self management
Monitored/managed by clinical team
Location for INR testing GP/Physician office Laboratory Anti-coagulationclinic
Other location
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INR Results
Date/Time
Value
Extension Consent (Patient Summary Page)
Date of consent for extension
Event Summary Extension
Treatment change/interruption
Date of Treatment change/interruption
Stroke/TIA
Date of Stroke/TIA
Type of stroke Primary IschemicStroke
Primaryintracerebralhemorrhage
Secondaryhemorrhagic ischemicstroke
Unknown
Bleed
Date of Bleeding event
Site of bleed
Severity of bleed Unknown Minor Non-majorclinically relevant
Major
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Outcome of bleed Resolved Ongoing Patient died
Unknown
Peripheral embolism
Date of Peripheral embolism
Myocardial Infarction/Acute Coronary Syndrome
Date of Myocardial Infarction/Acute Coronary Syndrome
Death
Date of Death
Primary cause of death Cardiovascular Non-cardiovascular
Other
Lost to follow-up
Lost to follow-up
Patient withdrew consent
Date of Patient withdrew consent
Dropdown values:
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Site of bleed - Intra-spinal
Subconjunctival
Intra-ocular / Retinal
GI Upper
GI Lower
Macroscopic haematuria
Abnormal uterine (metrorraghia)
Menorrhagia
Intra-articular
Intra-muscular (no compartment syndrome)
Intra-muscular (with compartment syndrome)
Epidural Hematoma
Epistaxis
Gingival
Intra-peritoneal
Retroperitoneal
Puncture site
Skin (Ecchymosis other than instrument site)
Hemoptysis
Haemo-pericardium
Haemothorax
Other
Subdural Hematoma
Unknown
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Follow-up Extension
Date of follow up
Extension 36 month record 48 month record 60 month record
72 month record 84 month record 96 month record
Have all of the events been entered so far No Yes
No death event was entered in the previous 12 months. Death is a primary
endpoint. Can you confirm that no death occurred in the previous 12
months?
No Yes
No stroke event was entered in the previous 12 months. Stroke is a primary
endpoint. Can you confirm that no stroke occurred in the previous 12
months?
No Yes
No bleed event was entered in the previous 12 months. Bleed is a primary
endpoint. Can you confirm that no bleed occurred in the previous 12
months?
No Yes
Principal investigator's PIN
