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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
Mid and South Essex 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 and Weston NHS Foundation Trust
East Kent Hospitals University NHS Foundation Trust
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE October 20, 2014
First Posted Date  ICMJE January 21, 2015
Last Update Posted Date August 29, 2019
Actual Study Start Date  ICMJE November 2013
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2015)
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year. [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
  • Rates of cardiac death and HHF at 30 days. [ Time Frame: 30 days ]
  • Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months. [ Time Frame: 12 months ]
  • TIMI flow post-PPCI. [ Time Frame: 1 week ]
  • Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L). [ Time Frame: One year ]
  • Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers [ Time Frame: 1 week ]
  • CMR substudy: Cardiac MRI in first week and at 6 months [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2015)
  • Rates of cardiac death and HHF at 30 days. [ Time Frame: 30 days ]
  • Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months. [ Time Frame: 12 months ]
  • TIMI flow post-PPCI. [ Time Frame: 30 days ]
  • Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L). [ Time Frame: One year ]
  • Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) hsTrop T and CK-MB. [ Time Frame: 1 week ]
  • CMR substudy: Cardiac MRI in first week and at 6 months (primary endpoint infarct size at 6 mths). [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)
Official Title  ICMJE Effect of Remote Ischaemic Conditioning on Clinical Outcomes in ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention (CONDI2/ERIC-PPCI)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • STEMI
  • Myocardial Reperfusion Injury
Intervention  ICMJE
  • 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.
  • Device: Control
    An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Remote ischemic conditioning
  • 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.
    Intervention: Device: Control
Publications * Hausenloy DJ, Kharbanda RK, Møller UK, Ramlall M, Aarøe J, Butler R, Bulluck H, Clayton T, Dana A, Dodd M, Engstrom T, Evans R, Lassen JF, Christensen EF, Garcia-Ruiz JM, Gorog DA, Hjort J, Houghton RF, Ibanez B, Knight R, Lippert FK, Lønborg JT, Maeng M, Milasinovic D, More R, Nicholas JM, Jensen LO, Perkins A, Radovanovic N, Rakhit RD, Ravkilde J, Ryding AD, Schmidt MR, Riddervold IS, Sørensen HT, Stankovic G, Varma M, Webb I, Terkelsen CJ, Greenwood JP, Yellon DM, Bøtker HE; CONDI-2/ERIC-PPCI Investigators. Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial. Lancet. 2019 Oct 19;394(10207):1415-1424. doi: 10.1016/S0140-6736(19)32039-2. Epub 2019 Sep 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2018)
5413
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2015)
2000
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Serbia,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02342522
Other Study ID Numbers  ICMJE CS/14/3/31002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE
  • 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
  • Mid and South Essex 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 and Weston NHS Foundation Trust
  • East Kent Hospitals University NHS Foundation Trust
Investigators  ICMJE
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
PRS Account University College, London
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP