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

Effect of Remote Ischaemic Conditioning on Clinical Outcomes in ST-segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention (CONDI2/ERIC-PPCI)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Reperfusion Injury; STEMI
• Intervention / Treatment: Device: Remote ischemic conditioning; Device: Control

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
• Enrollment (Actual): 5413
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of cardiac death and HHF at 30 days.	30 days
Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.	12 months
TIMI flow post-PPCI.	1 week
Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).	One year
Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers	1 week
CMR substudy: Cardiac MRI in first week and at 6 months	6 months

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: London School of Hygiene and Tropical Medicine; King's College London; Odense University Hospital; Aarhus University Hospital; Rigshospitalet, Denmark; The Leeds Teaching Hospitals NHS Trust; Norfolk and Norwich University Hospitals NHS Foundation Trust; University of Aarhus; Guy's and St Thomas' NHS Foundation Trust; East Kent Hospitals University NHS Foundation Trust; Sheffield Teaching Hospitals NHS Foundation Trust; Barts & The London NHS Trust; Central Denmark Region; Royal Free Hospital NHS Foundation Trust; Mid and South Essex NHS Foundation Trust; Manchester University NHS Foundation Trust; Brighton and Sussex University Hospitals NHS Trust; British Heart Foundation; Papworth Hospital NHS Foundation Trust; University Hospitals Bristol and Weston NHS Foundation Trust; East and North Hertfordshire NHS Trust; Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust; Portsmouth Hospitals NHS Trust; Aalborg University Hospital; Oxford University Hospitals NHS Trust; Imperial College Healthcare NHS Trust; Region of Southern Denmark; The Royal Wolverhampton Hospitals NHS Trust; University Hospitals Coventry and Warwickshire NHS Trust; The Danish Medical Research Council; Clinical Centre of Serbia; Military Medical Academy, Belgrade, Serbia; Hospital Universitario Central de Asturias; Region Zealand; University Hospitals of North Midlands NHS Trust; Blackpool Victoria Hospital; Heart of England NHS Trust; Kettering General Hospital NHS Foundation Trust; North Cumbria University Hospitals NHS Trust; United Lincolnshire Hospitals NHS Trust; Prehospital Emergency Medical Service, The North Denmark Region
• 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

Publications and helpful links

General Publications

• Hausenloy DJ, Kharbanda RK, Moller UK, Ramlall M, Aaroe 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, Lonborg 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, Sorensen HT, Stankovic G, Varma M, Webb I, Terkelsen CJ, Greenwood JP, Yellon DM, Botker 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2013
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: January 19, 2015
• First Posted (ESTIMATE): January 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: STEMI; Myocardial reperfusion injury; Cardioprotection; PPCI; Cardiovascular mortality; ST-elevation myocardial infarction; Myocardial infarct size; Remote Ischaemic Conditioning
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Cardiomyopathies; Reperfusion Injury; Myocardial Reperfusion Injury
• Other Study ID Numbers: CS/14/3/31002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED