STEMINCT02342522
Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)
A study testing Remote ischemic conditioning in people with STEMI and Myocardial Reperfusion Injury, run by University College, London at 35 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI, Myocardial Reperfusion Injury
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,413 participants
- Where
- 35 sitesin 4 countries
- Study dates
- Nov 2013to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
United Kingdom26 sites
William Harvey Hospital
Ashford
Basildon University Hospital
Basildon
Birmingham Heartlands Hospital
Birmingham
Blackpool Victoria Hospital
Blackpool
Royal Bournemouth Hospital
Bournemouth
Royal Sussex County Hospital
Brighton, Sussex
Bristol Royal Infirmary
Bristol
Papworth Hospital
Cambridge
Cumberland Infirmary
Carlisle
Coventry University Hospital
Coventry
Kettering General Hospital
Kettering
Leeds General Infirmary
Leeds
Lincoln County Hospital
Lincoln
Hammersmith Hospital
London
Kings College London Hospital
London
St Bartholomew's Hospital
London
St Thomas Hospital
London
The Royal Free Hospital
London
Manchester Royal Infirmary
Manchester
Norfolk and Norwich University Hospital
Norwich
John Radcliffe Hospital
Oxford
Queen Alexandra Hospital
Portsmouth
Northern General Hospital
Sheffield
Lister Hospital
Stevenage
Royal Stoke University Hospital
Stoke-on-Trent
New Cross Hospital
Wolverhampton
Denmark7 sites
Prehospital Emergency Medical Service, North Denmark Region
Aalborg, 9000
Aalborg University Hospital
Aalborg, 9100
Prehospital Emergency Medical Service, Central Denmark Region
Aarhus, 8200
Prehospital Emergency Medical Service, Region Zealand
Ballerup Municipality, 2750
Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense, 5000
Prehospital Emergency Medical Service , South Denmark Region
Vejle, 7100
Spain1 site
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
About this study
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)
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.
Read the 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).
- Conditions
- STEMI, Myocardial Reperfusion Injury
- Being tested
- Remote ischemic conditioning, Control
- Keywords
- Cardioprotection, STEMI, PPCI, Myocardial reperfusion injury, Myocardial infarct size, ST-elevation myocardial infarction, Remote Ischaemic Conditioning, Cardiovascular mortality
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
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.
ControlDevice
An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Active comparator | 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. Receives: Device: Remote ischemic conditioning |
| Sham control | Sham comparator | Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.
Measured: One year
Secondary outcomes (6)
Rates of cardiac death and HHF at 30 days.
Measured: 30 days
Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.
Measured: 12 months
TIMI flow post-PPCI.
Measured: 1 week
Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).
Measured: One year
Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers
Measured: 1 week
CMR substudy: Cardiac MRI in first week and at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startNov 2013
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,413 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, London School of Hygiene and Tropical Medicine, King's College London, Oxford University Hospitals NHS Trust, University of Aarhus, Copenhagen University Hospital, Rigshospitalet, 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
- Responsible party
- Sponsor
- Investigators
- Derek Hausenloy, MD PhD, Principal investigator, The Hatter Cardiovascular Institute, University College LondonHans Erik Botker, MD PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342522
- Sponsor's protocol ID
- CS/14/3/31002
- Status last verified
- Oct 2018
- First submitted
- 20 Oct 2014
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 31500849
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02342522
- Acronym / sponsor ID
- CS/14/3/31002
- Conditions
- STEMI, Myocardial Reperfusion Injury
- Keywords
- Cardioprotection, STEMI, PPCI, Myocardial reperfusion injury, Myocardial infarct size, ST-elevation myocardial infarction, Remote Ischaemic Conditioning, Cardiovascular mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,413 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- British Heart Foundation, London School of Hygiene and Tropical Medicine, King's College London, Oxford University Hospitals NHS Trust, University of Aarhus, Copenhagen University Hospital, Rigshospitalet, 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
- Study start
- Nov 2013 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Active comparator | Device: Remote ischemic conditioningAutoRIC 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 control | Sham comparator | Device: ControlSham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningAn 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. | Device | Remote ischemic conditioning |
| ControlAn automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied. | Device | Sham control |
Primary outcome
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.
Time frame: One year
6 secondary outcomes
Rates of cardiac death and HHF at 30 days.
Time frame: 30 days
Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.
Time frame: 12 months
TIMI flow post-PPCI.
Time frame: 1 week
Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).
Time frame: One year
Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers
Time frame: 1 week
CMR substudy: Cardiac MRI in first week and at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Derived from this study: PubMed 31500849Hausenloy 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Hausenloy, MD PhD principal investigator
The Hatter Cardiovascular Institute, University College London
Hans Erik Botker, MD PhD principal investigator
University of Aarhus
35 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with STEMI and Myocardial Reperfusion Injury, run by University College, London at 35 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United Kingdom, Denmark, Serbia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.