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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 : Active, not recruiting
First Posted : January 21, 2015
Last Update Posted : June 26, 2018
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 Universitetshospital
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).

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)
Study Start Date : November 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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 ]


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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
Denmark
Prehospital Emergency Medical Service, North Denmark Region
Aalborg, Denmark, 9000
Aalborg University Hospital
Aalborg, Denmark, 9100
Prehospital Emergency Medical Service, Central Denmark Region
Aarhus, Denmark, 8200
Prehospital Emergency Medical Service, Region Zealand
Ballerup, Denmark, 2750
Rigshospitalet
København, Denmark, 2100
Odense University Hospital
Odense, Denmark, 5000
Prehospital Emergency Medical Service , South Denmark Region
Vejle, Denmark, 7100
Serbia
Clinical Centre of Serbia
Belgrade, Serbia, 26000
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33011
United Kingdom
Royal Sussex County Hospital
Brighton, Sussex, United Kingdom
William Harvey Hospital
Ashford, United Kingdom
Basildon University Hospital
Basildon, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Papworth Hospital
Cambridge, United Kingdom
Cumberland Infirmary
Carlisle, United Kingdom
Coventry University Hospital
Coventry, United Kingdom
Kettering General Hospital
Kettering, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Lincoln County Hospital
Lincoln, United Kingdom
Hammersmith Hospital
London, United Kingdom
Kings College London Hospital
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
St Thomas Hospital
London, United Kingdom
The Royal Free Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Northern General Hospital
Sheffield, United Kingdom
Lister Hospital
Stevenage, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
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 Universitetshospital
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
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

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02342522     History of Changes
Obsolete Identifiers: NCT01857414
Other Study ID Numbers: CS/14/3/31002
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 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:
Myocardial Infarction
Reperfusion Injury
ST Elevation Myocardial Infarction
Myocardial Reperfusion Injury
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Pathologic Processes
Cardiomyopathies