Myocardial Infarction
Conditions
Keywords
myocardial infarction, percutaneous coronary intervention, exenatide, reperfusion injury, cardiac magnetic resonance
Brief summary
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
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.
Interventions
DRUGexenatide BYETTA® (Amylin-Lilly)
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.
DRUGSaline
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.
Sponsors
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct size | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | 6 month after primary PCI | Adverse events of exenatide such as hypoglycemia, nausea, vomiting, and chest pain aggravation were monitored during study period. |
| LV function | at admission and 6 month after primary PCI | Conventional and speckle tracking echocardiography was performed at initial presentation and 3 days and 6 months after primary PCI. |
| Clinical outcomes | 6 months after primary PCI | During 6-month follow up, clinical outcomes such as all death, repeated myocardial infarction or repeated PCI were also assessed. |
Countries
South Korea
Outcome results
None listed