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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02342522
Enrollment
5413
Registered
2015-01-21
Start date
2013-11-30
Completion date
2019-03-31
Last updated
2019-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Reperfusion Injury, STEMI

Keywords

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

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).

Interventions

DEVICERemote 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.

DEVICEControl

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.12 months
TIMI flow post-PPCI.1 week
Rates of cardiac death and HHF at 30 days.30 days
Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers1 week
CMR substudy: Cardiac MRI in first week and at 6 months6 months
Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).One year

Countries

Denmark, Serbia, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026