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 (GIPS-III) - GIPS-III
- Conditions
- preservation and remodeling of the left ventricles after acute myocardial infarction
- Registration Number
- EUCTR2009-018162-34-NL
- Lead Sponsor
- Thorax Center, Univeristy Medical Center Groningen, Groningen, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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 12 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;
- Verbal followed by written informed consent.
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
-rescue PCI after thrombolytic therapy;
-need for emergency coronary artery bypass grafting;
-creatinin >177 µmol/L measured pre-PCI;
- arterial pH <7.30 from blood gas analysis pre-PCI;
- Inability to provide informed consent;
- Younger than 18 years;
-Previous myocardial infarction;
- Mechanical ventilation;
- Diabetes;
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method