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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Active Comparator | 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. |
|
| Saline | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide BYETTA® (Amylin-Lilly) | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weon Kim, MD, PhD | Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital | Seoul | Seoul | 130-872 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19195607 | Background | Timmers L, Henriques JP, de Kleijn DP, Devries JH, Kemperman H, Steendijk P, Verlaan CW, Kerver M, Piek JJ, Doevendans PA, Pasterkamp G, Hoefer IE. Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury. J Am Coll Cardiol. 2009 Feb 10;53(6):501-10. doi: 10.1016/j.jacc.2008.10.033. | |
| 28286967 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| Saline | Drug | 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. |
|
|
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 |
| Huang M, Wei R, Wang Y, Su T, Li Q, Yang X, Chen X. Protective effect of glucagon-like peptide-1 agents on reperfusion injury for acute myocardial infarction: a meta-analysis of randomized controlled trials. Ann Med. 2017 Nov;49(7):552-561. doi: 10.1080/07853890.2017.1306653. Epub 2017 Mar 31. |
| 23868944 | Derived | Woo JS, Kim W, Ha SJ, Kim JB, Kim SJ, Kim WS, Seon HJ, Kim KS. Cardioprotective effects of exenatide in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of exenatide myocardial protection in revascularization study. Arterioscler Thromb Vasc Biol. 2013 Sep;33(9):2252-60. doi: 10.1161/ATVBAHA.113.301586. Epub 2013 Jul 18. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011183 | Postoperative Complications |
| D017670 |
| Sodium Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |