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

NCT02342522 | Completed DMC

• 1 other identifier: CS/14/3/31002
• Study Type: interventional
• Target: 5,413
• Locations: 4 countries
• Sites: 35

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.

Conditions

STEMI; Myocardial Reperfusion Injury

Keywords

Cardioprotection; STEMI; PPCI; Myocardial reperfusion injury; Myocardial infarct size; ST-elevation myocardial infarction; Remote Ischaemic Conditioning; Cardiovascular mortality

Outcome Measures

Primary Outcomes (1)

• Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.

  One year

Secondary Outcomes (6)

• 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

Study Arms (2)

Remote ischemic conditioning

ACTIVE COMPARATOR

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

Sham control

SHAM COMPARATOR

Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI.

Device: Control

Interventions

Remote ischemic conditioning DEVICE

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.

Remote ischemic conditioning

Control DEVICE

An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.

Sham control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Onset of STEMI symptoms within 12 hours, lasting for more than 30 minutes
• Patients older than 18 years
• 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)

You may not qualify if:

• Previous coronary artery bypass graft surgery
• Myocardial infarction within the previous 30 days
• Treatment with thrombolysis within the previous 30 days
• Left bundle branch block
• Patients treated with therapeutic hypothermia
• Conditions precluding use of RIC (paresis of upper limb, use of an a-v shunt)
• Life expectancy of less than 1 year due to non-cardiac pathology

Sponsors & Collaborators

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

Study Sites (35)

Prehospital Emergency Medical Service, North Denmark Region

Aalborg, 9000, Denmark

Location

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Prehospital Emergency Medical Service, Central Denmark Region

Aarhus, 8200, Denmark

Location

Prehospital Emergency Medical Service, Region Zealand

Ballerup Municipality, 2750, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Prehospital Emergency Medical Service , South Denmark Region

Vejle, 7100, Denmark

Location

Clinical Centre of Serbia

Belgrade, 26000, Serbia

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Royal Sussex County Hospital

Brighton, Sussex, United Kingdom

Location

William Harvey Hospital

Ashford, United Kingdom

Location

Basildon University Hospital

Basildon, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

Bristol Royal Infirmary

Bristol, United Kingdom

Location

Papworth Hospital

Cambridge, United Kingdom

Location

Cumberland Infirmary

Carlisle, United Kingdom

Location

Coventry University Hospital

Coventry, United Kingdom

Location

Kettering General Hospital

Kettering, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Lincoln County Hospital

Lincoln, United Kingdom

Location

Hammersmith Hospital

London, United Kingdom

Location

Kings College London Hospital

London, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

St Thomas Hospital

London, United Kingdom

Location

The Royal Free Hospital

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, United Kingdom

Location

Northern General Hospital

Sheffield, United Kingdom

Location

Lister Hospital

Stevenage, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Location

New Cross Hospital

Wolverhampton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31500849 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Reperfusion Injury

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cardiomyopathies; Reperfusion Injury; Postoperative Complications

Study Officials

• Derek Hausenloy, MD PhD

  The Hatter Cardiovascular Institute, University College London

  PRINCIPAL INVESTIGATOR

• Hans Erik Botker, MD PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: January 21, 2015
• Study Start: November 1, 2013
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 29, 2019

Record last verified: 2018-10

Locations

DK (7); SE (1); GB (26); ES (1)