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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507156
First Posted: July 25, 2007
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark
  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
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

Resource links provided by NLM:


Further study details as provided by Thomas Engstrom, Rigshospitalet, Denmark:

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

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

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

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
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
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


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

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 Submitted: July 23, 2007
First Posted: July 25, 2007
Last Update Posted: October 6, 2016
Last Verified: October 2016

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