This trial is active, not recruiting.

Condition st-segment myocardial infarction
Treatments standard primary pci, mechanical postconditioning
Phase phase 4
Sponsor Rigshospitalet, Denmark
Start date July 2007
End date November 2008
Trial size 200 participants
Trial identifier NCT00507156, KF 01 326257


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.
mechanical postconditioning
Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations
(Active Comparator)
Standard treatment (primary PCI)
standard primary pci
Acute re-opening of the occluded coronary artery

Primary Outcomes

Final infarct size evaluated by MR
time frame: 3 month

Secondary Outcomes

MACE (death, re-infarction, TLR)
time frame: 1, 15 month
Stent thrombosis
time frame: 15 month

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction
Description Please see above
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.