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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02197117
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : May 9, 2017
Information provided by (Responsible Party):
Derek Hausenloy, 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..

Condition or disease Intervention/treatment Phase
ST-segment Elevation Myocardial Infarction (STEMI) Device: Remote ischemic conditioning Device: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 519 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischaemic Conditioning in STEMI Patients Treated by thromboLYSIS: A Randomised Controlled Clinical Trial (the ERIC-LYSIS Study)
Study Start Date : March 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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.
Device: Remote ischemic conditioning
Sham Comparator: Control
Standard blood pressure cuff placed on upper arm and left un-inflated for 40 minutes, and then cuff is removed.
Device: Control

Primary Outcome Measures :
  1. Myocardial infarct size [ Time Frame: 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 :
  1. Acute kidney injury [ Time Frame: Measured by serum creatinine at 24 hours ]
    Measured by serum creatinine at 24 hours.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02197117

Victoria Hospital
Candos, Mauritius
Flacq Hospital
Flacq, Mauritius
Sir Seewoosagur Ramgoolam National Hospital
Pamplemousses, Mauritius
Dr AG Jeetoo Hospital
Port Louis, Mauritius
Jawaharlal Nehru Hospital
Rose-Belle, Mauritius
Sponsors and Collaborators
University College, London

Responsible Party: Derek Hausenloy, Professor in Cardiovascular Medicine, University College, London Identifier: NCT02197117     History of Changes
Other Study ID Numbers: ERIC-LYSIS
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by Derek Hausenloy, University College, London:
ST-segment elevation myocardial infarction (STEMI); thrombolysis, remote ischemic conditioning, myocardial infarct size, cardioprotection

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases