Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention

Not Applicable

• Conditions: ST-elevation Myocardial Infarction
• Interventions: Procedure: Remote ischemic conditioning

• Registration Number: NCT02431338
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2012-01
• Status Verified: 2015-04
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-30
• Last Update Submitted: 2015-04-30
• Study First Posted: 2015-05-01
• Last Update Posted: 2015-05-01
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 333

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Remote ischemic conditioning	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.

Primary Outcome Measures

Name	Time	Method
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]	4-years of follow-up	Data for the economic evaluation are collected from Danish nationwide registries and validated with medical record review. Charges from the Diagnosis Related Group (DRG) and the Danish Ambulatory Grouping System /DAGS) are used to calculate total cardiovascular medical care costs in the two treatment groups.

Trial Locations

Locations (1)

Department of Cardiology, Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark