Effect of Remote Ischemic Conditioning in Heart Attack Patients

Not Applicable

Completed

• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
• Interventions: Device: Control; Device: Remote ischemic conditioning

• Registration Number: NCT02197117
• Lead Sponsor: University College, London

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-07
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 519

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Standard blood pressure cuff placed on upper arm and left un-inflated for 40 minutes, and then cuff is removed.
Remote ischemic conditioning	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Acute kidney injury	Measured by serum creatinine at 24 hours	Measured by serum creatinine at 24 hours.

Trial Locations

Locations (5)

Jawaharlal Nehru Hospital; 🇲🇺 Rose-Belle, Mauritius

Dr AG Jeetoo Hospital; 🇲🇺 Port Louis, Mauritius

Sir Seewoosagur Ramgoolam National Hospital; 🇲🇺 Pamplemousses, Mauritius

Victoria Hospital; 🇲🇺 Candos, Mauritius

Flacq Hospital; 🇲🇺 Flacq, Mauritius