Goal 3: Advance Translational Research

Validating surrogate/intermediate clinical outcome endpoints for ST segment elevated myocardial infarction (STEMI)

The introduction of troponin assays has changed the criteria for myocardial infarction (MI), with much smaller myocardial damage now classified as an MI. Since to date, the FDA has not approved new agents based on their decreasing size of an MI, regulatory approval has required endpoints like death or heart failure that require large numbers of patients and long periods of time. Thus, it is difficult to attract industry support because of the cost to complete such studies. There is growing evidence that infarct size correlates with important clinical outcomes. If NHLBI can validate infarct size as an FDA-approvable endpoint, it would spur drug development.

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Idea No. 1003