Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study

Not Applicable

• Conditions: ST-elevation Myocardial Infarction (STEMI)
• Interventions: Procedure: Remote ischemic perconditioning

• Registration Number: NCT01665365
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-13
• Study First Posted: 2012-08-15
• Status Verified: 2013-08
• Primary Completion: 2013-09
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 251

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Remote ischemic perconditioning	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 (intervention group).

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events (MACCE)	5 years	MACCE defined as all-cause mortality, readmission for heart failure, myocardial infarction, and ischemic stroke/transient ischemic attack. Data are collected from Danish nationwide registries and medical records.

Secondary Outcome Measures

Name	Time	Method
LV-function and remodeling	5 years	LV-function and remodeling measured by echocardiography.

Trial Locations

Locations (1)

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