Clinical trial NCT02197117: Effect of Remote Ischemic Conditioning in Heart Attack Patients
Official title: Effect of Remote Ischaemic Conditioning in STEMI Patients Treated by thromboLYSIS: A Randomised Controlled Clinical Trial (the ERIC-LYSIS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Keywords: ST-segment elevation myocardial infarction (STEMI); thrombolysis, remote ischemic conditioning, myocardial infarct size, cardioprotection
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 519
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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..


Eligibility criteria: 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 -

Primary outcomes:
measure: Myocardial infarct size
timeFrame: 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 outcomes:
measure: Acute kidney injury
timeFrame: Measured by serum creatinine at 24 hours
Other outcomes:
Locations:
city: Candos
country: Mauritius
facility: Victoria Hospital
city: Flacq
country: Mauritius
facility: Flacq Hospital
city: Pamplemousses
country: Mauritius
facility: Sir Seewoosagur Ramgoolam National Hospital
city: Port Louis
country: Mauritius
facility: Dr AG Jeetoo Hospital
city: Rose-Belle
country: Mauritius
facility: Jawaharlal Nehru Hospital
Study officials:
References: