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Effect of additional treatment with EXenatide in patients with an Acute Myocardial Infarction (EXAMI): study protocol
Martijn Scholte1, Leo Timmers, Flip Jp Bernink
1Department of Cardiology, VU University Medical Center, De Boelelaan 11171081 HV Amsterdam, The Netherlands.
Insights
Exenatide, a type 2 diabetes drug, may reduce heart attack damage. The EXAMI trial investigates its potential to preserve cardiac function after acute myocardial infarction when added to standard treatment.
Area of Science:
- Cardiology
- Pharmacology
- Diabetes Research
Background:
- Myocardial infarction (MI) causes irreversible cardiomyocyte loss, impairing ventricular function and increasing mortality.
- Reducing infarct size is crucial for improving patient outcomes after MI.
- Glucagon-like peptide 1 receptor agonists, like exenatide, show potential cardioprotective effects in experimental studies.
Purpose of the Study:
- To evaluate the clinical outcome of exenatide infusion in patients with acute myocardial infarction (MI).
- To assess exenatide's effect on myocardial infarct size as a primary endpoint.
- To determine if exenatide offers a novel therapeutic option for preserving cardiac function post-MI.
Main Methods:
- The EXAMI trial is a multi-center, prospective, randomized, placebo-controlled study.
- 108 patients with acute MI, treated with primary percutaneous coronary intervention, were randomized to exenatide or placebo.
- Exenatide was administered as a bolus followed by continuous infusion for 72 hours.
- Myocardial infarct size was assessed using magnetic resonance imaging at 4 months.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- Exenatide may represent a novel therapeutic option for reducing infarct size.
- If proven effective, exenatide could preserve cardiac function in conjunction with reperfusion therapy for acute MI patients.
Background:
Myocardial infarction causes irreversible loss of cardiomyocytes and may lead to loss of ventricular function, morbidity and mortality. Infarct size is a major prognostic factor and reduction of infarct size has therefore been an important objective of strategies to improve outcomes. In experimental studies, glucagon-like peptide 1 and exenatide, a long acting glucagon-like peptide 1 receptor agonist, a novel drug introduced for the treatment of type 2 diabetes, reduced infarct size after myocardial infarction by activating pro-survival pathways and by increasing metabolic efficiency.
Methods:
The EXAMI trial is a multi-center, prospective, randomized, placebo controlled trial, designed to evaluate clinical outcome of exenatide infusion on top of standard treatment, in patients with an acute myocardial infarction, successfully treated with primary percutaneous coronary intervention. A total of 108 patients will be randomized to exenatide (5 μg bolus in 30 minutes followed by continuous infusion of 20 μg/24 h for 72 h) or placebo treatment. The primary end point of the study is myocardial infarct size (measured using magnetic resonance imaging with delayed enhancement at 4 months) as a percentage of the area at risk (measured using T2 weighted images at 3-7 days).
Discussion:
If the current study demonstrates cardioprotective effects, exenatide may constitute a novel therapeutic option to reduce infarct size and preserve cardiac function in adjunction to reperfusion therapy in patients with acute myocardial infarction.
Trial Registration:
ClinicalTrials.gov: NCT01254123.
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