Overview

This trial is active, not recruiting.

Condition st-elevation myocardial infarction (stemi)
Treatment remote ischemic perconditioning
Sponsor University of Aarhus
Collaborator Aarhus University Hospital
Start date February 2007
End date September 2013
Trial size 251 participants
Trial identifier NCT01665365, 30685

Summary

The aim of this prospective follow-up study is to investigate 5-year clinical outcome in patients with ST-elevation myocardial infarction undergoing remote ischemic conditioning before primary percutaneous coronary intervention.

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 (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention (intervention group).
remote ischemic perconditioning
Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention.
(No Intervention)
Primary percutaneous coronary intervention (control group).

Primary Outcomes

Measure
Major adverse cardiac and cerebrovascular events (MACCE)
time frame: 5 years

Secondary Outcomes

Measure
LV-function and remodeling
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Chest pain before admission to hospital within 12 h of onset, ST-segment elevation of > 0,1 mV in 2 or more contiguous leads, 18 years or older. Exclusion Criteria: - left bundle branch block, previous myocardial infarction, fibrinolytic treatment in the previous 30 days, previous coronary bypass surgery, left main stem stenosis requiring coronary bypass surgery, severe heart failure requiring mechanical ventilation or use of an intra-aortic balloon pump.

Additional Information

Official title Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study
Principal investigator Astrid D Sloth, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Aarhus.