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Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (ERIC-PPCI)

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ClinicalTrials.gov Identifier: NCT02342522
Recruitment Status : Recruiting
First Posted : January 21, 2015
Last Update Posted : May 16, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure in patients presenting with a ST-elevation myocardial infarction and treated by percutaneous coronary intervention.

Condition or disease Intervention/treatment Phase
STEMI Myocardial Reperfusion Injury Device: Remote ischemic conditioning Device: Sham control Phase 3

Detailed Description:
The ERIC-PPCI is a 2000 patient 30 UK site randomised controlled double-blind clinical trial which will investigate whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI). It also includes 2 sub-studies. The Biomarker sub-study will investigate the enzymatic infarct size at 6 months. The Cardiac Magnetic Resonance (CMR) sub-study will investigate infarct size at 6 months. This study is a research collaboration with Aarhus University in Denmark (CONDI2 trial ClinicalTrials.gov Identifier:NCT01857414).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischaemic Conditioning on Clinical Outcomes in ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention (ERIC-PPCI): A Multicentre Randomised Controlled Clinical Trial
Study Start Date : November 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Remote ischemic conditioning
On arrival at the hospital an AutoRIC device will be placed on the upper arm and an active RIC protocol will be delivered (4x5 min cycles of inflation to 220mmHg and deflation).
Device: Remote ischemic conditioning
An automated autoRIC™ cuff will be placed on the upper arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle which will be undertaken 4 times in total. For patients presenting with a systolic blood pressure (SBP)≥175mmHg, a manual blood pressure cuff will be used and inflated to 25 mmHg above systolic blood pressure.
Sham Comparator: Sham control
On arrival at the hospital an AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered (4x5 min cycles of simulated inflation and deflation).
Device: Sham control
An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.


Outcome Measures

Primary Outcome Measures :
  1. Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Rates of cardiac death and HHF at 30 days. [ Time Frame: 30 days ]
  2. Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months. [ Time Frame: 12 months ]
  3. TIMI flow post-PPCI. [ Time Frame: 30 days ]
  4. Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L). [ Time Frame: One year ]
  5. Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) hsTrop T and CK-MB. [ Time Frame: 1 week ]
  6. CMR substudy: Cardiac MRI in first week and at 6 months (primary endpoint infarct size at 6 mths). [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion criteria

  1. Onset of STEMI symptoms within 12 hours, lasting for more than 30 minutes
  2. Patients older than 18 years
  3. Suspected STEMI (ST-elevation at the J-point in two contiguous leads with the cut-off points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads)
  4. Eligibility for coronary angiography with follow on PPCI if indicated

Exclusion criteria

  1. Previous coronary artery bypass graft surgery
  2. Myocardial infarction (MI) within the previous 30 days
  3. Treatment with thrombolysis within the previous 30 days
  4. Left bundle branch block (LBBB)
  5. Patients treated with therapeutic hypothermia
  6. Conditions precluding use of RIC (paresis of upper limb, use of an a-v shunt)
  7. Life expectancy of less than 1 year due to non-cardiac pathology
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02342522


Contacts
Contact: Richard Evans +44 207 927 2665 Richard.Evans@lshtm.ac.uk
Contact: Manish Ramlall, BSc(Hons), MBChB +44 203 447 9888 mrmanish45@yahoo.co.uk

Locations
United Kingdom
St Thomas Hospital Recruiting
London, United Kingdom
Contact: Simon Redwood         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom
Contact: Rajesh Kharbanda         
Sponsors and Collaborators
University College, London
British Heart Foundation
London School of Hygiene and Tropical Medicine
King's College London
Oxford University Hospitals NHS Trust
University of Aarhus
Investigators
Principal Investigator: Derek Hausenloy, MD PhD The Hatter Cardiovascular Institute, University College London
More Information

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02342522     History of Changes
Other Study ID Numbers: CS/14/3/31002
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University College, London:
Cardioprotection
STEMI
PPCI
Myocardial reperfusion injury
Myocardial infarct size

Additional relevant MeSH terms:
Reperfusion Injury
ST Elevation Myocardial Infarction
Myocardial Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiomyopathies