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

Primary Purpose

ST-segment Elevation Myocardial Infarction (STEMI)

Status
Completed
Phase
Not Applicable
Locations
Mauritius
Study Type
Interventional
Intervention
Remote ischemic conditioning
Control
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction (STEMI) focused on measuring ST-segment elevation myocardial infarction (STEMI); thrombolysis, remote ischemic conditioning, myocardial infarct size, cardioprotection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 -

Sites / Locations

  • Victoria Hospital
  • Flacq Hospital
  • Sir Seewoosagur Ramgoolam National Hospital
  • Dr AG Jeetoo Hospital
  • Jawaharlal Nehru Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Remote ischemic conditioning

Control

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acute kidney injury
Measured by serum creatinine at 24 hours.

Full Information

First Posted
July 18, 2014
Last Updated
May 7, 2017
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT02197117
Brief Title
Effect of Remote Ischemic Conditioning in Heart Attack Patients
Acronym
ERIC-LYSIS
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College, London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction (STEMI)
Keywords
ST-segment elevation myocardial infarction (STEMI); thrombolysis, remote ischemic conditioning, myocardial infarct size, cardioprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
519 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemic conditioning
Arm Type
Active Comparator
Arm 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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Standard blood pressure cuff placed on upper arm and left un-inflated for 40 minutes, and then cuff is removed.
Intervention Type
Device
Intervention Name(s)
Remote ischemic conditioning
Intervention Type
Device
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Myocardial infarct size
Description
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.
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
Secondary Outcome Measure Information:
Title
Acute kidney injury
Description
Measured by serum creatinine at 24 hours.
Time Frame
Measured by serum creatinine at 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 -
Facility Information:
Facility Name
Victoria Hospital
City
Candos
Country
Mauritius
Facility Name
Flacq Hospital
City
Flacq
Country
Mauritius
Facility Name
Sir Seewoosagur Ramgoolam National Hospital
City
Pamplemousses
Country
Mauritius
Facility Name
Dr AG Jeetoo Hospital
City
Port Louis
Country
Mauritius
Facility Name
Jawaharlal Nehru Hospital
City
Rose-Belle
Country
Mauritius

12. IPD Sharing Statement

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Effect of Remote Ischemic Conditioning in Heart Attack Patients

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