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

Phase 4

Completed

• Conditions: ST-segment Myocardial Infarction
• Interventions: Procedure: Standard primary PCI; Procedure: Mechanical postconditioning

• Registration Number: NCT00507156
• Lead Sponsor: 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.

Detailed Description

Please see above

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-23
• Study First Submitted QC: 2007-07-23
• Study First Posted: 2007-07-25
• Primary Completion: 2008-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment	Standard primary PCI	Standard treatment (primary PCI)
Mek postcon	Mechanical postconditioning	Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.

Primary Outcome Measures

Name	Time	Method
Final infarct size evaluated by MR	3 month

Secondary Outcome Measures

Name	Time	Method
MACE (death, re-infarction, TLR)	1, 15 month
Stent thrombosis	15 month

Trial Locations

Locations (1)

Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen; 🇩🇰 Copenhagen, Denmark