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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University College, London
Sponsor:
Information provided by (Responsible Party):
Derek Hausenloy, University College, London
ClinicalTrials.gov Identifier:
NCT02197117
First received: July 18, 2014
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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 Intervention
ST-segment Elevation Myocardial Infarction (STEMI)
Device: Remote ischemic conditioning
Device: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Acute kidney injury [ Time Frame: Measured by serum creatinine at 24 hours ] [ Designated as safety issue: No ]
    Measured by serum creatinine at 24 hours.


Estimated Enrollment: 519
Study Start Date: March 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 -

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02197117

Contacts
Contact: Sudhirsen Kowlesseur sukowlessur@mail.gov.mu

Locations
Mauritius
Victoria Hospital Recruiting
Candos, Mauritius
Contact: N Domah         
Principal Investigator: N Domah         
Flacq Hospital Recruiting
Flacq, Mauritius
Contact: A Ackbarkhan         
Principal Investigator: A Ackbarkhan         
Sir Seewoosagur Ramgoolam National Hospital Recruiting
Pamplemousses, Mauritius
Contact: V Balgobin         
Principal Investigator: V Balgobin         
Dr AG Jeetoo Hospital Recruiting
Port Louis, Mauritius
Contact: J Lutchoo         
Principal Investigator: J Lutchoo         
Jawaharlal Nehru Hospital Recruiting
Rose-Belle, Mauritius
Contact: R Dhuny         
Principal Investigator: R Dhuny         
Sponsors and Collaborators
University College, London
  More Information

No publications provided

Responsible Party: Derek Hausenloy, Professor in Cardiovascular Medicine, University College, London
ClinicalTrials.gov Identifier: NCT02197117     History of Changes
Other Study ID Numbers: ERIC-LYSIS
Study First Received: July 18, 2014
Last Updated: July 21, 2014
Health Authority: Mauritius: Ministry of Health and Quality of Life

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

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

ClinicalTrials.gov processed this record on October 23, 2014