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Table 2 Definitions for primary outcome assessment in the FIELD study

From: The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]

Myocardial infarction
Definite myocardial infarction = criterion 1; or any two of criteria 2 to 4; or criterion 5
1. New Q waves: new pathological Q waves (or Q-S pattern) of at least 0.03 seconds in width in at least 2 leads in the same lead group (in the absence of left bundle branch block)
2. Evolutionary ST-T wave changes: evolution of an injury current lasting more than one day and present in at least 2 leads in the same lead group: for example, ST elevation of 2 mm or more in anterior leads, or 1 mm or more in inferior leads followed by T-wave inversion of 1 mm or more; this requires a minimum of two traces taken at least one day apart
3. Ischemic pain: history of typical ischemic pain lasting for at least 15 minutes and unresponsive to sublingual nitrates (if given)
4. Biochemical markers: elevation of CK or CKMB enzymes to over twice the upper limit of normal (for the laboratory) after the attack or elevation of troponin T to more than 0.1 μg/L or troponin I to levels above the upper limit of normal (for the laboratory)
5. Postmortem diagnosis: autopsy showing evidence of acute myocardial infarction.
Death
Coronary heart disease death = any of 1.1 to 1.7
1. Coronary
1.1 Definite fatal myocardial infarction: death following definite acute myocardial infarction in the preceding 28 days (and without an unrelated noncoronary cause of death), or autopsy-proven recent acute myocardial infarction
1.2 Sudden cardiac death: death occurring within one hour of onset of new cardiac symptoms or unwitnessed death after last having been seen without new symptoms; in each case, without any noncoronary disease that could have been rapidly fatal and without having been confined to hospital or other institution because of illness within 24 hours of death
1.3 Possible myocardial infarction: death in hospital with possible myocardial infarction (that is, typical ischaemic pain and ECG and enzyme results do not fulfil the criteria for definite myocardial and there is no good evidence for another event)
1.4 Resuscitated sudden death: documented cardiac arrest (in or out of hospital), after being resuscitated from what would have been sudden death; patient lives for more than one hour (hours to weeks).
1.5 Heart failure: death due to heart failure (prior grade 3–4 dyspnoea, NYHA) without any defined noncoronary cause
1.6 Death after coronary revascularisation: death (in the same admission) after any coronary revascularisation procedure (CABG or PTCA).
1.7 Other coronary: death where the underlying cause is certified as coronary (and there is no evidence for a noncoronary cause of death, clinically or at autopsy)
2. Noncoronary cardiac: death for which the underlying cause is certified as noncoronary cardiac disease
3. Vascular (noncardiac): death which is certified as vascular but not coronary disease: for example, cerebrovascular accident, pulmonary embolism, complications of peripheral vascular disease or uncontrolled hypertension
4. Cancer: death for which the underlying cause is certified as malignant neoplasm
5. Trauma: death where the underlying cause is certified as a wound or injury either accidental or inflicted
6. Suicide: death for which the underlying cause is certified as deliberate and voluntary taking of one's own life
7. Other: other cause of death not specified above.