Myocardial Protection of Exenatide in AMI

Study Overview
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Brief Summary
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Experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has significant cardiovascular protective effects in various conditions. The investigators examined whether conventional use of exenatide at the time of primary percutaneous coronary intervention would reduce the infarct size in patients with ST-segment elevation myocardial infarction (STEMI).

Detailed Description
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In this proof-of-concept trial, we assessed the effects of acute-phase adjunctive exenatide therapy in patients with STEMI. Infarct size after STEMI was evaluated by both cardiac magnetic resonance image and cardiac biomarkers compared with standard treatment. LV function was assessed by conventional and speckle tracking echocardiography. During 6-month follow up, the safety/tolerability of exenatide and clinical outcomes were also assessed.

Official Title
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Cardioprotective Effects of Exenatide in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention ; Results of Exenatide Myocardial Protection In REvascularization (EMPIRE) Study

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: exenatide BYETTA® (Amylin-Lilly)
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 20 and 79 years patients presenting with first ST-segment elevation myocardial infarction Thrombolysis in Myocardial Infarction [TIMI] flow grade 0) Exclusion Criteria: cardiac arrest ventricular fibrillation cardiogenic shock hemodynamic instability suspicious stent thrombosis left bundle branch block previous acute myocardial infarction previous coronary artery bypass operation significant valvular heart disease primary myocardial disease atrial fibrillation significant hepatic or renal dysfunction, hypoglycaemia, diabetic ketoacidosis active infection or chronic inflammatory disease malignancy women who were pregnant or who were of childbearing age

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exenatide<br>Drug: Exenatide 10 μg subcutaneous and 10 μg intravenously injection of exenatide BYETTA® (Amylin-Lilly) 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days. | Drug: exenatide BYETTA® (Amylin-Lilly)<br>* After informed consent was obtained, patients who met the enrollment criteria were randomly assigned to either the control group or the exenatide group. Patients assigned to exenatide were treated with 10 μg subcutaneous and 10 μg intravenously injection of exenatide BYETTA® (Amylin-Lilly) 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.<br>* Other names: Saline;|
| Placebo Comparator: Saline<br>Drug: Saline 10 μg subcutaneous and 10 μg intravenously injection of equivalent volume of normal saline 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days. | Drug: Saline<br>* After informed consent was obtained, patients who met the enrollment criteria were randomly assigned to either the control group or the exenatide group. Patients assigned to saline were treated with 10 μg subcutaneous and 10 μg intravenously injection of equivalent volume of normal saline 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.<br>* Other names: Exenatide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size | Infarct size was assessed by measuring the release of creatine kinase-MB and troponin I during 72 hours and by performing cardiac magnetic resonance imaging on 1 month after infarction. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | Adverse events of exenatide such as hypoglycemia, nausea, vomiting, and chest pain aggravation were monitored during study period. | 6 month after primary PCI | 
| LV function | Conventional and speckle tracking echocardiography was performed at initial presentation and 3 days and 6 months after primary PCI. | at admission and 6 month after primary PCI | 
| Clinical outcomes | During 6-month follow up, clinical outcomes such as all death, repeated myocardial infarction or repeated PCI were also assessed. | 6 months after primary PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, percutaneous coronary intervention, exenatide, reperfusion injury, cardiac magnetic resonance