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

NCT ID: NCT01665365

Last Updated: 2015-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2015-12-31

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.

Detailed Description

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Conditions

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ST-elevation Myocardial Infarction (STEMI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1. 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).

Group Type EXPERIMENTAL

Remote ischemic perconditioning

Intervention Type PROCEDURE

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.

2.

Primary percutaneous coronary intervention (control group).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Astrid D Sloth, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Department of Cardiology, Aarhus University Hospital, Skejby

Aarhus N, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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30685

Identifier Type: -

Identifier Source: org_study_id

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