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

Study Overview
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Brief Summary
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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.

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

Conditions
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ST-elevation Myocardial Infarction (STEMI)

Intervention / Treatment
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* Procedure: Remote ischemic perconditioning


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Remote ischemic perconditioning<br>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). | Procedure: Remote ischemic perconditioning<br>* 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.<br>|
| No Intervention: 2.<br>Primary percutaneous coronary intervention (control group). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events (MACCE) | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV-function and remodeling | LV-function and remodeling measured by echocardiography. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Remote ischemic conditioning, Clinical outcome