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

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ClinicalTrials.gov Identifier: NCT00507156
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : October 6, 2016
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark

Brief Summary:

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 or disease Intervention/treatment Phase
ST-segment Myocardial Infarction Procedure: Standard primary PCI Procedure: Mechanical postconditioning Phase 4

Detailed Description:
Please see above

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction
Study Start Date : July 2007
Primary Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Final infarct size evaluated by MR [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. MACE (death, re-infarction, TLR) [ Time Frame: 1, 15 month ]
  2. Stent thrombosis [ Time Frame: 15 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507156

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

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
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016

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