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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Rigshospitalet, Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00835848
First received: February 3, 2009
Last updated: August 28, 2014
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: Exenatide
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI in Patients With STEMI

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Infarct size by MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiel death after 1 and 15 months. [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: August 2014
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 - 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00835848

Locations
Denmark
Heart Center, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
University Hospital, Gentofte, Copenhagen
Investigators
Study Chair: Thomas Engstrom, MD, PhD, DSci Rigshospitalet, Denmark
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Consultant PhD, DSci, Thomas Engstrom, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00835848     History of Changes
Other Study ID Numbers: KF 01 326257 b
Study First Received: February 3, 2009
Last Updated: August 28, 2014
Health Authority: Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:
ST-segment elevation myocardial infarction
Primary PCI
Postconditioning

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 11, 2014