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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
| London School of Hygiene and Tropical Medicine | OTHER |
| King's College London | OTHER |
| Oxford University Hospitals NHS Trust |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of cardiac death and HHF at 30 days. | 30 days | |
| Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months. | 12 months | |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek Hausenloy, MD PhD | The Hatter Cardiovascular Institute, University College London | Principal Investigator |
| Hans Erik Botker, MD PhD | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prehospital Emergency Medical Service, North Denmark Region | Aalborg | 9000 | Denmark | |||
| Aalborg University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31500849 | Derived | 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. |
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| OTHER |
| University of Aarhus | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Aalborg University Hospital | OTHER |
| Odense University Hospital | OTHER |
| Hospital Universitario Central de Asturias | OTHER |
| Clinical Centre of Serbia | OTHER |
| Military Medical Academy, Belgrade, Serbia | OTHER |
| Central Denmark Region | OTHER |
| Region of Southern Denmark | OTHER |
| Prehospital Emergency Medical Service, The North Denmark Region | UNKNOWN |
| Region Zealand | OTHER |
| The Danish Medical Research Council | OTHER |
| Aarhus University Hospital | OTHER |
| North Cumbria University Hospitals NHS Trust | OTHER |
| Barts & The London NHS Trust | OTHER |
| Mid and South Essex NHS Foundation Trust | OTHER |
| Sheffield Teaching Hospitals NHS Foundation Trust | OTHER |
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| Manchester University NHS Foundation Trust | OTHER_GOV |
| Norfolk and Norwich University Hospitals NHS Foundation Trust | OTHER |
| The Royal Wolverhampton Hospitals NHS Trust | OTHER_GOV |
| Royal Free Hospital NHS Foundation Trust | OTHER |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| East and North Hertfordshire NHS Trust | OTHER_GOV |
| Portsmouth Hospitals NHS Trust | OTHER_GOV |
| United Lincolnshire Hospitals NHS Trust | OTHER |
| Papworth Hospital NHS Foundation Trust | OTHER_GOV |
| Blackpool Victoria Hospital | OTHER |
| Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | OTHER_GOV |
| Brighton and Sussex University Hospitals NHS Trust | OTHER |
| University Hospitals Coventry and Warwickshire NHS Trust | OTHER |
| University Hospitals of North Midlands NHS Trust | OTHER |
| Heart of England NHS Trust | OTHER |
| Kettering General Hospital NHS Foundation Trust | OTHER |
| Imperial College Healthcare NHS Trust | OTHER |
| University Hospitals Bristol and Weston NHS Foundation Trust | OTHER |
| East Kent Hospitals University NHS Foundation Trust | OTHER_GOV |
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| Control | Device | An automated autoRICâ„¢ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied. |
|
| TIMI flow post-PPCI. |
| 1 week |
| Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L). | One year |
| Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers | 1 week |
| CMR substudy: Cardiac MRI in first week and at 6 months | 6 months |
| Aalborg |
| 9100 |
| Denmark |
| Prehospital Emergency Medical Service, Central Denmark Region | Aarhus | 8200 | Denmark |
| Prehospital Emergency Medical Service, Region Zealand | Ballerup Municipality | 2750 | Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| Prehospital Emergency Medical Service , South Denmark Region | Vejle | 7100 | Denmark |
| Clinical Centre of Serbia | Belgrade | 26000 | Serbia |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Royal Sussex County Hospital | Brighton | Sussex | 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 |
| 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 | United Kingdom |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D015428 | Myocardial Reperfusion Injury |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009202 | Cardiomyopathies |
| D015427 | Reperfusion Injury |
| D011183 | Postoperative Complications |
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