Myocardial Protection of Exenatide in AMI

Condition(s) targeted: Myocardial Infarction

Intervention: exenatide BYETTA® (Amylin-Lilly) (Drug); Saline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Kyunghee University Medical Center

Official(s) and/or principal investigator(s):
Weon Kim, MD, PhD, Principal Investigator, Affiliation: Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital

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).

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Infarct size

Secondary outcome:

Number of Participants with Adverse Events

LV function

Clinical outcomes

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.

Minimum age: 20 Years. Maximum age: 79 Years. Gender(s): Both.

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

Kyung Hee University Hospital, Seoul 130-872, Korea, Republic of

Related publications:

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.

Starting date: September 2009
Last updated: April 18, 2012