Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI

Myocardial Infarction Clinical Trial

— POSTCON II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835848
• Other study ID #: KF 01 326257 b
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2009
• Last updated: May 4, 2015
• Start date: January 2009
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2015
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Heart Center, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size by MRI		3 months	No
Secondary	Cardiel death after 1 and 15 months.		15 months	No