Effect of Remote Ischemic Conditioning in Heart Attack Patients

NCT ID: NCT02197117

Last Updated: 2017-05-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

519 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-08-31

Brief Summary

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New treatments are required to improve health outcomes in patients with ischemic heart disease. This is especially so in developing countries such as Mauritius in which optimal therapy for acute myocardial infarction may not be widely available. For example for patients presenting with a heart attack (caused by a blockage in one of the heart blood vessels) the treatment of choice would be to remove the blockage by primary percutaneous coronary intervention (PCI) using an angioplasty balloon and put a stent (a spring-like structure) to keep the artery opened. However, PCI is not widely available in Mauritius and heart attack patients are given clot-busting therapy to remove the blockage, but this is not as effective as PCI.

Therefore, in this research study we investigate a new cheap treatment that may help protect the heart against damage during a heart attack, called remote ischemic conditioning (RIC), in which a blood pressure cuff is placed on the upper arm and inflated for 5 minute and deflated for 5 minutes a cycle which is repeated 4 times in total in patients presenting with a heart attack. By temporarily depriving oxygen and nutrients to the arm with the blood pressure cuff a protective signal can be relayed to the heart to reduce the amount of damage occurring during the heart attack and thereby prevent the onset of heart failure.

Study hypothesis: Remote ischaemic conditioning will reduce the amount of damage occurring to the heart muscle during a heart attack..

Detailed Description

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Conditions

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ST-segment 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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Remote ischemic conditioning

Standard blood pressure cuff placed on upper arm and inflated to 200 mmHg. The cuff is left inflated at this level for 5 minutes and then rapidly deflated to 0 mmHg left deflated for 5 minutes0 this cycle is repeated 4 times in total.

Group Type ACTIVE_COMPARATOR

Remote ischemic conditioning

Intervention Type DEVICE

Control

Standard blood pressure cuff placed on upper arm and left un-inflated for 40 minutes, and then cuff is removed.

Group Type SHAM_COMPARATOR

Control

Intervention Type DEVICE

Interventions

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Remote ischemic conditioning

Intervention Type DEVICE

Control

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Presentation within 12 hours of onset of chest pain
* ECG showing ST-segment elevation of ≥0.1mV in two contiguous leads (≥0.2mV in leads V1-V3)

Exclusion Criteria

-None -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Derek Hausenloy

Professor in Cardiovascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Victoria Hospital

Candos, , Mauritius

Site Status

Flacq Hospital

Centre de Flacq, , Mauritius

Site Status

Sir Seewoosagur Ramgoolam National Hospital

Pamplemousses, , Mauritius

Site Status

Dr AG Jeetoo Hospital

Port Louis, , Mauritius

Site Status

Jawaharlal Nehru Hospital

Rose Belle, , Mauritius

Site Status

Countries

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Mauritius

Other Identifiers

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ERIC-LYSIS

Identifier Type: -

Identifier Source: org_study_id

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