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OpenTrials
Completed

NCT Number: NCT01580514

Myocardial Protection of Exenatide in AMI

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).

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyung Hee University Hospital

Seoul, 130-872, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Saline

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.

Other names: Exenatide

Primary outcomes

  1. Infarct size

    Time frame: 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 outcomes

  1. Number of Participants with Adverse Events

    Time frame: 6 month after primary PCI

    Adverse events of exenatide such as hypoglycemia, nausea, vomiting, and chest pain aggravation were monitored during study period.

  2. LV function

    Time frame: 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.

  3. Clinical outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Official study 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

Acronym: EMPIRE

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 19, 2012
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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