Postconditioning used for the limitation of infarct size in patients with ST-elevation myocardial infarction (POSTCON). - POSTCO

Phase 1

Active, not recruiting

Conditions: Patients with ST-segment elevation myocardial infarction (STEMI) are routinely treated with primary PCI (pPCI) as a world wide standard. Glucagon like peptide (GLP1) is a genuine hormone created in the gut and with well characterized receptors in heart muscle. Previous studies have proven it to be safe in human and intravenous administration for 72 hours have shown it to reduce infarct size in pPCI.

Registration Number: EUCTR2007-001221-10-DK

Lead Sponsor: Rigshospitalet, University of Copenhagen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

Patients > 18 years submitted for acut pPCI because of STEMI.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Multivessel disease. Lesions that can not be treated with stent. Previous Q-wave MI. Impaired renal function. Previous CABG. Pregnancy. Diabetic ketoacidosis or hypoglycemia (plasma glucose < 3.3. mmol/l).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: After reopening of the infarct related artery by pPCI, patients are randomized to either GLP-1 or saline administration as one intracoronary bolus. The administration is done by means of the guiding catheter that is also used for the pPCI. Following 4 weeks magnetic resonnance (MR) is used to evaluta whether GLP-1 has reduced final infarct size, which is expected. ;Secondary Objective: To evaluate if GLP1 reduces major cardiovascular endpoints (death, reinfarction, re-intervention on target vessel).;Primary end point(s): Infarct size by MR, echocardiography and enzymemarker elevation.

Secondary Outcome Measures