Date of onset of MI symptoms
Item
1. Date of onset of MI symptoms
date
Time of onset of MI symptoms
Item
1. Time of onset of MI symptoms
time
Date of MI diagnosis
Item
2. Date of MI diagnosis
date
Time of MI diagnosis
Item
2. Time of MI diagnosis
date
Event details Cardiac biomarkers
Item
3. Event details: Cardiac biomarkers - peak value supporting diagnosis (specify test and result)
boolean
Event details ECG changes
Item
3. Event details: [A2] ECG changes
boolean
Event details Symptoms of ischemia
Item
3. Event details: [A3] Symptoms of ischemia
boolean
Event details PCI without stent thrombosis
Item
3. Event details: [A4] Associated with PCI without stent thrombosis
boolean
Event details PCI and stent thrombosis
Item
3. Event details: [A5] Associated with PCI and stent thrombosis confirmed by angiography or autopsy
boolean
Event details Associated with CABG
Item
3. Event details: [A6] Associated with CABG
boolean
Event details Imaging evidence
Item
3. Event details: [A7] Imaging evidence
boolean
Event details Sudden death
Item
3. Event details: [A8] Sudden, unexpected death, including cardiac arrest
boolean
Event details acute myocardial infarction
Item
3. Event details: [A9] Pathological findings of acute myocardial infarction at autopsy
boolean
Treatments and interventions Thrombolytic treatment
Item
4. Treatments and interventions: [1] Thrombolytic treatment
boolean
Treatments and interventions Parenteral anti-coagulant treatment
Item
4. Treatments and interventions: [2] Parenteral anti-coagulant treatment
boolean
Treatments and interventions Parenteral anti-platelet treatment
Item
4. Treatments and interventions: [3] Parenteral anti-platelet treatment
boolean
Treatments and interventions Coronary revascularisation
Item
4. Treatments and interventions: [4] Coronary revascularisation
boolean
Item
4. Treatments and interventions: [4] If Coronary revascularisation, select one
integer
Code List
4. Treatments and interventions: [4] If Coronary revascularisation, select one
Treatments and interventions Other cardiac procedure
Item
4. Treatments and interventions: [5] Other cardiac procedure (e.g., intra-aortic balloon, left ventricular assist device, pacemaker)
boolean
narrative
Item
6. Provide narrative
text
Date documents sent to CEC Document Group
Item
7. Date documents sent to CEC Document Group
date
Item
8. Adjudication
text
Code List
8. Adjudication
CL Item
Non-fatal MI (35)
CL Item
Does not meet criteria for myocardial infarction (NC)
criteria myocardial infarction comment
Item
If criteria for myocardial infarction not met, comment
text
Hospitalisation for unstable angina
Item
[36] Meets criteria for secondary endpoint: Hospitalisation for unstable angina
boolean
Item
9. Classification of MI
integer
Code List
9. Classification of MI
CL Item
Myocardial infarction diagnosed post-randomisation (80)
Item
If acute, select one
text
Code List
If acute, select one
CL Item
No recent revascularisation, baseline biomarkers not elevated - Rise/fall biomarkers >99th %ile URL (A25)
CL Item
No recent revascularisation, post-MI baseline biomarkers elevated - biomarker decreasing prior to new suspect MI then re-elevation >50% of (A26)
CL Item
previous value (previous value)
CL Item
Sudden unexpected cardiac death involving cardiac arrest, often with symptoms of myocardial ischemia, accompanied by new ST (A08)
CL Item
elevation/LBBB, fresh thrombus by coronary angiography/autopsy, but dying before blood obtained, or appearance of cardiac biomarkers (elevation/LBBB, fresh thrombus by coronary angiography/autopsy, but dying before blood obtained, or appearance of cardiac biomarkers)
CL Item
Within 24 hours post-PCI, either 1) rise of CK-MB; OR 2) pathological findings of acute MI. Subtype is related to stent thrombosis (A27)
CL Item
Within 72 hours post-CABG, either 1) rise of CK-MB + at least 1 additional criteria; OR 2) pathological findings of acute MI. (A28)
CL Item
Pathological findings of acute myocardial infarction at post mortem (A09)
Item
If myocardial infarction diagnosed post-randomisation, select one
text
Code List
If myocardial infarction diagnosed post-randomisation, select one
CL Item
Development of new pathological Q waves with or without symptoms (A13)
CL Item
Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (A07)
CL Item
Pathological findings of a healed or healing myocardial infarction (A14)
Item
10. STEMI / NSTEMI
text
Code List
10. STEMI / NSTEMI
CL Item
Not applicable (X)
Item
11. Q wave/Non-Q wave
text
Code List
11. Q wave/Non-Q wave
CL Item
Q wave undetermined - no ECG available (A24)
CL Item
Type 1: Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as plaque erosion and/or rupture, fissuring, or (A17)
CL Item
dissection (dissection)
CL Item
Type 2: Myocardial infarction secondary to ischemia due to either increased oxygen demand or decreased supply, e.g. coronary artery spasm, coronary (A18)
CL Item
embolism, anemia, arrhythmias, hypertension, or hypotension (embolism, anemia, arrhythmias, hypertension, or hypotension)
CL Item
Type 3: Sudden unexpected cardiac death often with symptoms of myocardial ischemia, accompanied by new ST elevation or new LBBB, or fresh thrombus (A19)
CL Item
in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers (in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers)
CL Item
Type 4a: Myocardial infarction associated with PCI (A20)
CL Item
Type 4b: Myocardial infarction associated with stent thrombosis as documented by angiography or at autopsy (A21)
CL Item
Type 5: Myocardial infarction associated with CABG (A22)
Item
13. Was this event related to a stent thrombosis?
text
Code List
13. Was this event related to a stent thrombosis?
Item
14. Unstable angina adjudication: 1. Adjudication
text
Code List
14. Unstable angina adjudication: 1. Adjudication
CL Item
Ischemic discomfort at rest associated with ECG changes leading to hospitalisation (D01)
CL Item
Ischemic discomfort at rest regardless of ECG changes leading to hospitalisation AND revascularisation during the same admission (D02)
CL Item
Ischemic discomfort at rest in hospital associated with ECG changes (D03)
CL Item
Ischemic discomfort at rest in hospital without ECG changes resulting in revascularisation during the same admission (D04)
Unstable angina adjudication ischemic discomfort
Item
14. Unstable angina adjudication: 2. Was ischemic discomfort at rest > 10 minutes?
boolean
Date of adjudication
Item
15. Date of adjudication
date
Trigger number
Item
16. Trigger number
text
Item
17. CEC Status
integer
CL Item
Coordinator Screen check (2)
CL Item
Ready for review (4)
CL Item
In Phase I review (5)
CL Item
Queried (InForm) (6)
CL Item
Additional documents required (7)
CL Item
In Phase II committee (8)
CL Item
Completed event (11)
CL Item
No event to adjudicate (12)
CL Item
QC Random sample (13)
CL Item
In Translation (14)
Date of status change
Item
18. Date of status change
date
Item
19. Physician review #1: Physician
integer
Code List
19. Physician review #1: Physician
Physician review 1 Date sent to reviewer
Item
19. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
19. Physician review #1: Date received from reviewer
date
Item
19. Physician review #2: Physician
integer
Code List
19. Physician review #2: Physician
Physician review 2 Date sent to reviewer
Item
19. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
19. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
21. CEC Coordinator comments
text
CV event number
Item
22. CV event number
text
Adverse event reference identifier
Item
23. Adverse event reference identifier
text
Adverse event term
Item
24. Adverse event term
text