Clinical trial NCT02342522: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STEMI
Myocardial Reperfusion Injury
Keywords: Cardioprotection
STEMI
PPCI
Myocardial reperfusion injury
Myocardial infarct size
ST-elevation myocardial infarction
Remote Ischaemic Conditioning
Cardiovascular mortality
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: London School of Hygiene and Tropical Medicine
name: King's College London
name: Oxford University Hospitals NHS Trust
name: University of Aarhus
name: Rigshospitalet, Denmark
name: Aalborg University Hospital
name: Odense University Hospital
name: Hospital Universitario Central de Asturias
name: Clinical Centre of Serbia
name: Military Medical Academy, Belgrade, Serbia
name: Central Denmark Region
name: Region of Southern Denmark
name: Prehospital Emergency Medical Service, The North Denmark Region
name: Region Zealand
name: The Danish Medical Research Council
name: Aarhus University Hospital
name: North Cumbria University Hospitals NHS Trust
name: Barts & The London NHS Trust
name: Mid and South Essex NHS Foundation Trust
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: The Leeds Teaching Hospitals NHS Trust
name: Manchester University NHS Foundation Trust
name: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: The Royal Wolverhampton Hospitals NHS Trust
name: Royal Free Hospital NHS Foundation Trust
name: Guy's and St Thomas' NHS Foundation Trust
name: East and North Hertfordshire NHS Trust
name: Portsmouth Hospitals NHS Trust
name: United Lincolnshire Hospitals NHS Trust
name: Papworth Hospital NHS Foundation Trust
name: Blackpool Victoria Hospital
name: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
name: Brighton and Sussex University Hospitals NHS Trust
name: University Hospitals Coventry and Warwickshire NHS Trust
name: University Hospitals of North Midlands NHS Trust
name: Heart of England NHS Trust
name: Kettering General Hospital NHS Foundation Trust
name: Imperial College Healthcare NHS Trust
name: University Hospitals Bristol and Weston NHS Foundation Trust
name: East Kent Hospitals University NHS Foundation Trust
First posted: 2015-01-21
Enrollment: 5413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.
timeFrame: One year
Secondary outcomes:
measure: Rates of cardiac death and HHF at 30 days.
timeFrame: 30 days
measure: Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.
timeFrame: 12 months
measure: TIMI flow post-PPCI.
timeFrame: 1 week
measure: Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).
timeFrame: One year
measure: Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers
timeFrame: 1 week
measure: CMR substudy: Cardiac MRI in first week and at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Prehospital Emergency Medical Service, North Denmark Region
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Prehospital Emergency Medical Service, Central Denmark Region
city: Ballerup
country: Denmark
facility: Prehospital Emergency Medical Service, Region Zealand
city: København
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Prehospital Emergency Medical Service , South Denmark Region
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
state: Sussex
city: Ashford
country: United Kingdom
facility: William Harvey Hospital
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary
city: Coventry
country: United Kingdom
facility: Coventry University Hospital
city: Kettering
country: United Kingdom
facility: Kettering General Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: Kings College London Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: St Thomas Hospital
city: London
country: United Kingdom
facility: The Royal Free Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: The Hatter Cardiovascular Institute, University College London
name: Derek Hausenloy, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Hans Erik Botker, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.