Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI

Overview

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.

Full Title of Study: “Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI in Patients With STEMI”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2009

Interventions

  • Drug: Exenatide
    • 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.
  • Drug: Saline
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Placebo Comparator: Saline
    • Isotonic saline infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

Clinical Trial Outcome Measures

Primary Measures

  • Infarct size by MRI
    • Time Frame: 3 months

Secondary Measures

  • Cardiel death after 1 and 15 months.
    • Time Frame: 15 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Collaborator
    • University Hospital, Gentofte, Copenhagen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Thomas Engstrom, Chief consultant – Rigshospitalet, Denmark
  • Overall Official(s)
    • Thomas Engstrom, MD, PhD, DSci, Study Chair, Rigshospitalet, Denmark

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