Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)

• ClinicalTrials.gov Identifier: NCT02342522
• Recruitment Status: Completed
• First Posted: January 21, 2015
• Last Update Posted: August 29, 2019
• Sponsor: University College, London
• 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: October 20, 2014
• First Posted Date: January 21, 2015
• Last Update Posted Date: August 29, 2019
• Actual Study Start Date: November 2013
• Actual Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)
• 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)
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• STEMI
• Myocardial Reperfusion Injury

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 22, 2018): 5413
• Original Estimated Enrollment (submitted: January 19, 2015): 2000
• Actual Study Completion Date: March 2019
• Actual Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, Serbia, Spain, United Kingdom

Administrative Information

• NCT Number: NCT02342522
• Other Study ID Numbers: CS/14/3/31002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: University College, London
• Study Sponsor: University College, London

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

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

• PRS Account: University College, London
• Verification Date: October 2018