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Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction (POSTCON)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00507156
First received: July 23, 2007
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning.

The study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.


Condition Intervention Phase
ST-segment Myocardial Infarction
Procedure: Standard primary PCI
Procedure: Mechanical postconditioning
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Final infarct size evaluated by MR [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MACE (death, re-infarction, TLR) [ Time Frame: 1, 15 month ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 15 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mek postcon
Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.
Procedure: Mechanical postconditioning
Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations
Active Comparator: Standard treatment
Standard treatment (primary PCI)
Procedure: Standard primary PCI
Acute re-opening of the occluded coronary artery

Detailed Description:

Please see above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients more than 18 years
  • STEMI < 12 hours
  • TIMI 0-1 in infarct related artery

Exclusion Criteria:

  • Multivessel disease (stenoses in non-infarct related arteries >70%)
  • Cardiogenic shock
  • Left main occlusions
  • Lesions that cannot be treated with stents
  • Previous CABG
  • Pregnancy
  • Severe renal insufficiency
  • Previous extensive Q-wave infarction
  • LBBB
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507156

Locations
Denmark
Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Thomas Engstrom, D.Sci., PhD Cheif Consultant
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Engstrom, Chief Consultant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00507156     History of Changes
Other Study ID Numbers: KF 01 326257
Study First Received: July 23, 2007
Last Updated: November 10, 2014
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014