Effect of Remote Ischemic Conditioning in Heart Attack Patients

Study Overview
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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..

Official Title
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Effect of Remote Ischaemic Conditioning in STEMI Patients Treated by thromboLYSIS: A Randomised Controlled Clinical Trial (the ERIC-LYSIS Study)

Conditions
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ST-segment Elevation Myocardial Infarction (STEMI)

Intervention / Treatment
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* Device: Remote ischemic conditioning
* Device: Control


Participation Criteria
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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 -

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 |
| --- | --- |
| Active Comparator: Remote ischemic conditioning<br>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. | Device: Remote ischemic conditioning<br> <br> |
| Sham Comparator: Control<br>Standard blood pressure cuff placed on upper arm and left un-inflated for 40 minutes, and then cuff is removed. | Device: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarct size | Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis. | Measured by 24 hr area under the curve serum CK-MB and Troponin-T sampled a time 0, 6, 12, and 24 hrs post-thrombolysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury | Measured by serum creatinine at 24 hours. | Measured by serum creatinine at 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-segment elevation myocardial infarction (STEMI); thrombolysis, remote ischemic conditioning, myocardial infarct size, cardioprotection