Metabolic modulation with metformin to reduce heart failure after acute myocardial infarction: Glycometabolic Intervention as adjunct to Primary percutaneous coronary intervention in ST elevation myocardial infarction (GIPS-III)

Phase 2

Completed

Conditions: Heart Failure
reduced left ventricular ejection fraction
10019280

Registration Number: NL-OMON39113

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 380

Inclusion Criteria

Inclusion criteria are:
- The diagnosis acute MI defined by chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 6 hours before hospital admission, and an ECG recording with ST- segment elevation of more than 0.1 mV in 2 or more leads.
- First myocardial infarction;
- Successful primary PCI (TIMI 2/3);
- At least one stent sized >= 3.0 mm;
- Eligible for CMR imaging;
- BMI<40;
- no claustrofobia;
- no pacemaker, ICD, etc;
- Informed consent.

Exclusion Criteria

exclusion criteria are:
- Rescue PCI after thrombolytic therapy;
- Need for emergency coronary artery bypass grafting;
- Inability to provide informed consent;
- Younger than 18 years old;
- Previous documented myocardial infarction;
- Artificial breathing support;
- Diabetes mellitus;
- Algemene toestand van de patient die, op basis van de klinische inschatting van de behandeld arts en/of de onderzoeker, niet toestaat dat de patient deelneemt aan deze studie. General condition which, according to the clinical judgment of the investigator and/or treating physician, does not allow the patient to participate in the study
- Contra-indication to metformin (see safety);
- The existence of a life-threatening disease with a life-expectancy of less than 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the GIPS-III is to evaluate the efficacy of metformin<br /><br>treatment compared with placebo in adjunction to optimal reperfusion therapy<br /><br>for acute MI on left ventricular ejection fraction 4 months after randomisation<br /><br>as measured with CMR.</p><br>

Secondary Outcome Measures