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

Study Description

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 Design

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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)
Actual Study Start Date :	November 2013
Actual Primary Completion Date :	March 2019
Actual Study Completion Date :	March 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year. [ Time Frame: One year ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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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:

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)

Exclusion criteria:

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

Contacts and Locations