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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02342522
Other study ID # CS/14/3/31002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date March 2019

Study information

Verified date October 2018
Source University College, London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Other known NCT identifiers
  • NCT01857414

Recruitment information / eligibility

Status Completed
Enrollment 5413
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Remote ischemic conditioning
An automated autoRICâ„¢ 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.
Control
An automated autoRICâ„¢ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.

Locations

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

Sponsors (42)

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

Countries where clinical trial is conducted

Denmark,  Serbia,  Spain,  United Kingdom, 

Outcome

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