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

Read More

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

Read More

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