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

STEMI Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342522
• Other study ID #: CS/14/3/31002
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Myocardial Reperfusion Injury
• Reperfusion Injury
• STEMI

Intervention

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.
• Control
An automated autoRIC™ 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