Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI in Patients With STEMI
Overview
- Phase
- Phase 4
- Intervention
- Exenatide
- Conditions
- Myocardial Infarction
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Infarct size by MRI
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Both pre- and postconditioning seem to protect cardiomyocytes during reperfusion therapy. Investigations both ex vivo and in vivo suggest that a gut derived hormone, Glucagon-Like-Peptide-1 (GLP-1), is able to reduce reperfusioninjury after myocardial ischemia. Results from our own laboratory have shown a marked reduction in infarct size when rat hearts in a Langendorf preparation were exposed to the GLP-1 analogue, exendin-4. The investigators want to investigate to what extent this effect can be translated to humans in the setting of acute STEMI treated with primary PCI when evalutaed by cardiac magnetic resonance imaging.
Investigators
Thomas Engstrom
Chief consultant
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •More than 18 years of age.
- •STEMI less than 12 hours from onset of pain. STEMI defined as as ST-segment elevation in 2 contiguous electrocardiographic leads of \>0.1 mV in V4 - V6 or limb leads II, III and aVF, or \>0.2 mV in lead V1 - V
- •TIMI 0-1 in infarct related artery.
- •Oral and written informed consent.
Exclusion Criteria
- •Multivessel disease defined by one or more stenoses \>70% in diameter in the non infarct related artery.
- •Previous myocardial infarction.
- •Stent trombosis.
- •Previous CABG.
- •Less than TIMI 2 following wiring and predilatation of the infarct related artery but prior to postconditioning or placebo treatment.
- •Renal insufficiency (creatinin \>200).
- •Pregnancy or lactation.
- •Diabetic ketoacidose eller hypoglycemia (plasma glukose \< 2.5 mmol/l).
- •Pancreatitis.
Arms & Interventions
Exenatide
25 μg Byetta (Lilly, Exenatide) is added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.
Intervention: Exenatide
Saline
Isotonic saline infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.
Intervention: Saline
Outcomes
Primary Outcomes
Infarct size by MRI
Time Frame: 3 months
Secondary Outcomes
- Cardiel death after 1 and 15 months.(15 months)