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

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Rigshospitalet

Status and phase

Completed
Phase 4

Conditions

ST-segment Myocardial Infarction

Treatments

Procedure: Standard primary PCI
Procedure: Mechanical postconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT00507156
KF 01 326257

Details and patient eligibility

About

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.

Full description

Please see above

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Mek postcon
Experimental group
Description:
Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.
Treatment:
Procedure: Mechanical postconditioning
Standard treatment
Active Comparator group
Description:
Standard treatment (primary PCI)
Treatment:
Procedure: Standard primary PCI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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