Clinical trial NCT01580514: Myocardial Protection of Exenatide in AMI
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: myocardial infarction
percutaneous coronary intervention
exenatide
reperfusion injury
cardiac magnetic resonance
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 127
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infarct size
timeFrame: 1 month
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 6 month after primary PCI
measure: LV function
timeFrame: at admission and 6 month after primary PCI
measure: Clinical outcomes
timeFrame: 6 months after primary PCI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital
name: Weon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.