Effect of Remote Ischemic Conditioning in Heart Attack Patients (ERIC-LYSIS)

University College London (UCL)

Status: Completed

Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

Treatments: Device: Remote ischemic conditioning; Device: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02197117

ERIC-LYSIS

Details and patient eligibility

About

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..

Enrollment: 519 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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519 participants in 2 patient groups

Remote ischemic conditioning

Active Comparator group

Description:

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.

Treatment:

Device: Remote ischemic conditioning

Control

Sham Comparator group

Description:

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

Treatment:

Device: Control