Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)
Primary Purpose
STEMI, Myocardial Reperfusion Injury
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Remote ischemic conditioning
Control
Sponsored by
About this trial
This is an interventional treatment trial for STEMI focused on measuring Cardioprotection, STEMI, PPCI, Myocardial reperfusion injury, Myocardial infarct size, ST-elevation myocardial infarction, Remote Ischaemic Conditioning, Cardiovascular mortality
Eligibility 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
Sites / Locations
- Prehospital Emergency Medical Service, North Denmark Region
- Aalborg University Hospital
- Prehospital Emergency Medical Service, Central Denmark Region
- Prehospital Emergency Medical Service, Region Zealand
- Rigshospitalet
- Odense University Hospital
- Prehospital Emergency Medical Service , South Denmark Region
- Clinical Centre of Serbia
- Hospital Universitario Central de Asturias
- Royal Sussex County Hospital
- William Harvey Hospital
- Basildon University Hospital
- Birmingham Heartlands Hospital
- Blackpool Victoria Hospital
- Royal Bournemouth Hospital
- Bristol Royal Infirmary
- Papworth Hospital
- Cumberland Infirmary
- Coventry University Hospital
- Kettering General Hospital
- Leeds General Infirmary
- Lincoln County Hospital
- Hammersmith Hospital
- Kings College London Hospital
- St Bartholomew's Hospital
- St Thomas Hospital
- The Royal Free Hospital
- Manchester Royal Infirmary
- Norfolk and Norwich University Hospital
- John Radcliffe Hospital
- Queen Alexandra Hospital
- Northern General Hospital
- Lister Hospital
- Royal Stoke University Hospital
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Remote ischemic conditioning
Sham control
Arm Description
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.
Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI.
Outcomes
Primary Outcome Measures
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.
Secondary Outcome Measures
Rates of cardiac death and HHF at 30 days.
Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.
TIMI flow post-PPCI.
Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).
Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers
CMR substudy: Cardiac MRI in first week and at 6 months
Full Information
NCT ID
NCT02342522
First Posted
October 20, 2014
Last Updated
August 28, 2019
Sponsor
University College, London
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
1. Study Identification
Unique Protocol Identification Number
NCT02342522
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
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
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI, Myocardial Reperfusion Injury
Keywords
Cardioprotection, STEMI, PPCI, Myocardial reperfusion injury, Myocardial infarct size, ST-elevation myocardial infarction, Remote Ischaemic Conditioning, Cardiovascular mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5413 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote ischemic conditioning
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI.
Intervention Type
Device
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.
Primary Outcome Measure Information:
Title
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Rates of cardiac death and HHF at 30 days.
Time Frame
30 days
Title
Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.
Time Frame
12 months
Title
TIMI flow post-PPCI.
Time Frame
1 week
Title
Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).
Time Frame
One year
Title
Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers
Time Frame
1 week
Title
CMR substudy: Cardiac MRI in first week and at 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Hausenloy, MD PhD
Organizational Affiliation
The Hatter Cardiovascular Institute, University College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans Erik Botker, MD PhD
Organizational Affiliation
Department of Clinical Medicine, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prehospital Emergency Medical Service, North Denmark Region
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Prehospital Emergency Medical Service, Central Denmark Region
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Prehospital Emergency Medical Service, Region Zealand
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Rigshospitalet
City
København
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Prehospital Emergency Medical Service , South Denmark Region
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Clinical Centre of Serbia
City
Belgrade
ZIP/Postal Code
26000
Country
Serbia
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Royal Sussex County Hospital
City
Brighton
State/Province
Sussex
Country
United Kingdom
Facility Name
William Harvey Hospital
City
Ashford
Country
United Kingdom
Facility Name
Basildon University Hospital
City
Basildon
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
Country
United Kingdom
Facility Name
Papworth Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
Country
United Kingdom
Facility Name
Coventry University Hospital
City
Coventry
Country
United Kingdom
Facility Name
Kettering General Hospital
City
Kettering
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Lincoln
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
Country
United Kingdom
Facility Name
Kings College London Hospital
City
London
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
St Thomas Hospital
City
London
Country
United Kingdom
Facility Name
The Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Portsmouth
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
Country
United Kingdom
Facility Name
Lister Hospital
City
Stevenage
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31500849
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.
Results Reference
derived
Learn more about this trial
Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)
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