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Trial record 1 of 1 for:    Condi-2/Eric-PPCI
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Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)

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ClinicalTrials.gov Identifier: NCT02342522
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
British Heart Foundation
London School of Hygiene and Tropical Medicine
King's College London
Oxford University Hospitals NHS Trust
University of Aarhus
Rigshospitalet, Denmark
Aalborg University Hospital
Odense University Hospital
Hospital Universitario Central de Asturias
Clinical Centre of Serbia
Military Medical Academy, Belgrade, Serbia
Central Denmark Region
Region of Southern Denmark
Prehospital Emergency Medical Service, The North Denmark Region
Region Zealand
The Danish Medical Research Council
Aarhus University Hospital
North Cumbria University Hospitals NHS Trust
Barts & The London NHS Trust
Basildon and Thurrock University Hospitals NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
Manchester University NHS Foundation Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
The Royal Wolverhampton Hospitals NHS Trust
Royal Free Hospital NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
East and North Hertfordshire NHS Trust
Portsmouth Hospitals NHS Trust
United Lincolnshire Hospitals NHS Trust
Papworth Hospital NHS Foundation Trust
Blackpool Victoria Hospital
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Brighton and Sussex University Hospitals NHS Trust
University Hospitals Coventry and Warwickshire NHS Trust
University Hospitals of North Midlands NHS Trust
Heart of England NHS Trust
Kettering General Hospital NHS Foundation Trust
Imperial College Healthcare NHS Trust
University Hospitals Bristol NHS Foundation Trust
East Kent Hospitals University NHS Foundation Trust
Information provided by (Responsible Party):
University College, London

Brief Summary:
The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure at 12 months 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: Control Not Applicable

Detailed Description:
The CONDI2/ERIC-PPCI trial is a randomised controlled clinical trial investigating whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in 5400 patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5413 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 (CONDI2/ERIC-PPCI)
Actual Study Start Date : November 2013
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Arm Intervention/treatment
Active Comparator: Remote ischemic conditioning
AutoRIC device will be placed on the upper arm and an active RIC protocol will be delivered (4x5 min cycles of inflation to 200mmHg and deflation) prior to PPCI.
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.

Sham Comparator: Sham control
Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI.
Device: Control
An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.




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: 1 week ]
  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) cardiac biomarkers [ Time Frame: 1 week ]
  6. CMR substudy: Cardiac MRI in first week and at 6 months [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 cutoff 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)

Exclusion criteria:

  1. Previous coronary artery bypass graft surgery
  2. Myocardial infarction within the previous 30 days
  3. Treatment with thrombolysis within the previous 30 days
  4. Left bundle branch block
  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

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


Locations
Show Show 35 study locations
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
Rigshospitalet, Denmark
Aalborg University Hospital
Odense University Hospital
Hospital Universitario Central de Asturias
Clinical Centre of Serbia
Military Medical Academy, Belgrade, Serbia
Central Denmark Region
Region of Southern Denmark
Prehospital Emergency Medical Service, The North Denmark Region
Region Zealand
The Danish Medical Research Council
Aarhus University Hospital
North Cumbria University Hospitals NHS Trust
Barts & The London NHS Trust
Basildon and Thurrock University Hospitals NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
Manchester University NHS Foundation Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
The Royal Wolverhampton Hospitals NHS Trust
Royal Free Hospital NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
East and North Hertfordshire NHS Trust
Portsmouth Hospitals NHS Trust
United Lincolnshire Hospitals NHS Trust
Papworth Hospital NHS Foundation Trust
Blackpool Victoria Hospital
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Brighton and Sussex University Hospitals NHS Trust
University Hospitals Coventry and Warwickshire NHS Trust
University Hospitals of North Midlands NHS Trust
Heart of England NHS Trust
Kettering General Hospital NHS Foundation Trust
Imperial College Healthcare NHS Trust
University Hospitals Bristol NHS Foundation Trust
East Kent Hospitals University NHS Foundation Trust
Investigators
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Principal Investigator: Derek Hausenloy, MD PhD The Hatter Cardiovascular Institute, University College London
Principal Investigator: Hans Erik Botker, MD PhD Department of Clinical Medicine, Aarhus University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02342522    
Obsolete Identifiers: NCT01857414
Other Study ID Numbers: CS/14/3/31002
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: October 2018
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
ST-elevation myocardial infarction
Remote Ischaemic Conditioning
Cardiovascular mortality
Additional relevant MeSH terms:
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Reperfusion Injury
Myocardial Reperfusion Injury
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Cardiomyopathies