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Myocardial Protection of Exenatide in AMI (EMPIRE)

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
exenatide BYETTA® (Amylin-Lilly)
Saline
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, percutaneous coronary intervention, exenatide, reperfusion injury, cardiac magnetic resonance

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyung Hee University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exenatide

Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants with Adverse Events
Adverse events of exenatide such as hypoglycemia, nausea, vomiting, and chest pain aggravation were monitored during study period.
LV function
Conventional and speckle tracking echocardiography was performed at initial presentation and 3 days and 6 months 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.

Full Information

First Posted
April 13, 2012
Last Updated
April 18, 2012
Sponsor
Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01580514
Brief Title
Myocardial Protection of Exenatide in AMI
Acronym
EMPIRE
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, percutaneous coronary intervention, exenatide, reperfusion injury, cardiac magnetic resonance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
exenatide BYETTA® (Amylin-Lilly)
Other Intervention Name(s)
Saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Exenatide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Infarct size
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
Adverse events of exenatide such as hypoglycemia, nausea, vomiting, and chest pain aggravation were monitored during study period.
Time Frame
6 month after primary PCI
Title
LV function
Description
Conventional and speckle tracking echocardiography was performed at initial presentation and 3 days and 6 months after primary PCI.
Time Frame
at admission and 6 month after primary PCI
Title
Clinical outcomes
Description
During 6-month follow up, clinical outcomes such as all death, repeated myocardial infarction or repeated PCI were also assessed.
Time Frame
6 months after primary PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weon Kim, MD, PhD
Organizational Affiliation
Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19195607
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.
Results Reference
background
PubMed Identifier
28286967
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.
Results Reference
derived
PubMed Identifier
23868944
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.
Results Reference
derived

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Myocardial Protection of Exenatide in AMI

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