Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI (POSTCON II)

May 4, 2015 updated by: Thomas Engstrom, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Heart Center, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size by MRI
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiel death after 1 and 15 months.
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

University Hospital, Gentofte, Copenhagen

Investigators

  • Study Chair: Thomas Engstrom, MD, PhD, DSci, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF 01 326257 b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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