Date of procedure
Item
1. Date of procedure
date
Start time of procedure
Item
1. Start time of procedure
time
Item
2. Revascularisation procedure
text
Code List
2. Revascularisation procedure
CL Item
PCI - single vessel (CA)
CL Item
PCI - multiple vessels (CC)
CL Item
Revascularisation procedure attempted but not successful (C09)
Item
If PCI - single vessel, select one
text
Code List
If PCI - single vessel, select one
CL Item
without stent (C01)
PCI single vessel with stent Bare metal
Item
If PCI - single vessel with stent: C02 Bare metal
boolean
number of stents bare metal single vessel
Item
If PCI - single vessel with stent (bare metal), indicate number of stents
integer
PCI single vessel with stent Drug-eluting
Item
If PCI - single vessel with stent: C03 Drug-eluting
boolean
number of stents drug-eluting single vessel
Item
If PCI - single vessel with stent (drug-eluting), indicate number of stents
integer
Item
If PCI - multiple vessels, select one
text
Code List
If PCI - multiple vessels, select one
CL Item
without stent (C04)
PCI multiple vessels with stent Bare metal
Item
If PCI - multiple vessels with stent: C05 Bare metal
boolean
number of stents bare metal multiple vessels
Item
If PCI - multiple vessels with stent (bare metal), indicate number of stents
integer
PCI multiple vessels with stent Drug-eluting
Item
If PCI - multiple vessels with stent: C06 Drug-eluting
boolean
number of stents drug-eluting multiple vessels
Item
If PCI - multiple vessels with stent (drug-eluting), indicate number of stents
integer
CABG Arterial graft
Item
If CABG: C07 Arterial graft
boolean
CABG arterial graft number
Item
Number of grafts
integer
CABG Saphenous vein graft
Item
If CABG: C08 Saphenous vein graft
boolean
CABG Saphenous vein graft number
Item
Number of grafts
integer
Item
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
text
Code List
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
ischemic discomfort at rest
Item
4. Did subject have ischemic discomfort at rest?
boolean
ischemic disomfort prompting coronary revascularisation
Item
Did ischemic disomfort at rest prompt coronary revascularisation (PCI or CABG) during the same hospitalisation?
boolean
ischemic discomfort resulting in hospital transfer
Item
Did ischemic discomfort at rest result in hospital transfer for the purpose of coronary revascularisation?
boolean
ischemic discomfort less than 10 minutes
Item
Was ischemic discomfort at rest > 10 minutes?
text
Other interventions ECG
Item
5. Other interventions: [6] ECG
boolean
Other interventions ECG
Item
5. Other interventions: [7] Cardiac biomarkers
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
6. Adjudication
text
Code List
6. Adjudication
CL Item
Urgent coronary revascularisation for myocardial ischemia (70)
CL Item
Does not meet criteria for urgent coronary revscularisation for myocardial ischemia (NC)
criteria for urgent coronary revscularisation for myocardial ischemia not met
Item
If criteria for urgent coronary revscularisation for myocardial ischemia not met, comment
text
Non-urgent coronary revascularisation
Item
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [71] Non-urgent coronary revascularisation
boolean
Revascularisation was a treatment for MI
Item
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [99] Revascularisation was a treatment for MI
boolean
Item
9. Was this event related to a stent thrombosis?
text
Code List
9. Was this event related to a stent thrombosis?
Item
10. Additional Findings: 1. Adjudication
integer
Code List
10. Additional Findings: 1. Adjudication
CL Item
Non-fatal MI (35)
Item
10. Additional Findings: 2. Classification of MI
integer
Code List
10. Additional Findings: 2. Classification of MI
CL Item
Prior MI (occurred after randomisation) (39)
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
Annotated Trial Design Page 206 of 307 (Annotated Trial Design Page 206 of 307)
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 prior MI (occurred after randomisation), select one
text
Code List
If prior MI (occurred after 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. Additional Findings: 3. STEMI / NSTEMI
text
Code List
10. Additional Findings: 3. STEMI / NSTEMI
CL Item
Not applicable (X)
Item
10. Additional Findings: 4. Q wave/Non-Q wave
text
Code List
10. Additional Findings: 4. Q wave/Non-Q wave
CL Item
Q wave undetermined - no ECG available (A24)
Item
10. Additional Findings: 5. Type of MI
text
Code List
10. Additional Findings: 5. Type of MI
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 (A19)
CL Item
thrombus in a coronary artery, but dying before blood samples obtained or before the appearance of cardiac biomarkers (thrombus 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)
Date of adjudication
Item
11. Date of adjudication
date
Trigger number
Item
12. Trigger number
text
Item
13. 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
14. Date of status change
date
Item
15. Physician review #1: Physician
integer
Code List
15. Physician review #1: Physician
Physician review 1 Date sent to reviewer
Item
15. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
15. Physician review #1: Date received from reviewer
date
Item
16. Physician review #2: Physician
integer
Code List
16. Physician review #2: Physician
Physician review 2 Date sent to reviewer
Item
16. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
16. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
17. CEC Coordinator comments
text
CV event number
Item
18. CV event number
text
Adverse event reference identifier
Item
19. Adverse event reference identifier
text
Adverse event term
Item
20. Adverse event term
text