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OpenTrials
Completed

NCT Number: NCT00507156

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

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.

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Key information

Conditions

ST-segment Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

About this study

Please see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Primary PCI

Procedure

Acute re-opening of the occluded coronary artery

Mechanical postconditioning

Procedure

Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations

Primary outcomes

  1. Final infarct size evaluated by MR

    Time frame: 3 month

Secondary outcomes

  1. MACE (death, re-infarction, TLR)

    Time frame: 1, 15 month

  2. Stent thrombosis

    Time frame: 15 month

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction

Acronym: POSTCON

Important dates

Study start
2007
Primary completion
2008
First posted
Jul 25, 2007
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.