Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI in Patients With STEMI

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Exenatide
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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 - V3. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exenatide<br>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. | Drug: Exenatide<br>* Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 25 μg Byetta (Lilly, Exenatide) and 0.1% human albumine are 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.<br>|
| Placebo Comparator: Saline<br>Isotonic saline infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours. | Drug: Saline<br>* Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 0.1% human albumine 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size by MRI |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiel death after 1 and 15 months. |  | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-segment elevation myocardial infarction, Primary PCI, Postconditioning