This trial is active, not recruiting.

Condition st-elevation myocardial infarction
Treatment remote ischemic conditioning
Sponsor University of Aarhus
Collaborator Aarhus University Hospital
Start date February 2007
End date January 2012
Trial size 333 participants
Trial identifier NCT02431338, 48241


The aim of this study is to investigate the cost-effectiveness of remote ischemic conditioning as an adjunct to primary percutaneous coronary intervention from the perspective of a Danish healthcare system.

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
Remote ischemic conditioning through intermittent arm ischemia with four cycles of alternating 5-minute inflation followed by 5-minute deflation of a blood pressure cuff performed in the ambulance during transport to primary percutaneous coronary intervention.
remote ischemic conditioning RIC
Intermittent arm ischemia through four cycles of alternating 5-minute inflation followed by 5-minute deflation of a blood pressure cuff placed around the upper arm.
(No Intervention)
Standard treatment with primary percutaneous coronary intervention alone.

Primary Outcomes

Incremental cost-effectiveness ratio (ICER) = [difference in total cardiovascular medical care costs between treatment groups] / [difference in major adverse cardiac and cerebrovascular event (MACCE)-free survival between treatment groups]
time frame: 4-years of follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: (1) age ≥ 18 years, (2) symptom duration of ≤ 12 hours prior to admission, and (3) ST-segment elevation ≥ 0.1 mV in two or more contiguous electrocardiogram (ECG) leads Exclusion Criteria: (1) diagnosis not confirmed during hospital admission, (2) history of previous myocardial infarction, (3) previous CABG, and (4) chest pain > 12 hours prior to admission

Additional Information

Official title Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction
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.