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

NCT ID: NCT02431338

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2015-09-30

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.

Conditions

ST-elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Remote ischemic conditioning

Intervention Type: PROCEDURE

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.

Control group

Standard treatment with primary percutaneous coronary intervention alone.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Remote ischemic conditioning

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.

Intervention Type: PROCEDURE

Other Intervention Names

RIC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astrid D Sloth, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Aarhus University Hospital, Denmark

Locations

Department of Cardiology, Aarhus University Hospital

Aarhus N, , Denmark

Countries

Denmark

Other Identifiers

48241

Identifier Type: -

Identifier Source: org_study_id