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| ID | Type | Description | Link |
|---|---|---|---|
| MR/V001620/1 | Other Grant/Funding Number | Medical Research Council |
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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
| Imperial College Healthcare Nissen Fund | UNKNOWN |
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ORBITA-COSMIC is a randomised, double-blinded, placebo controlled trial of the coronary sinus reducer (CSR). The investigators will compare the effects of CSR versus placebo on myocardial perfusion on MRI, exercise time and symptoms in 50 participants with refractory angina and ischaemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSR | Active Comparator | Coronary Sinus Reducer implantation |
|
| Placebo | Placebo Comparator | Placebo procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Sinus Reducer | Device | Coronary Sinus Reducer implantation according to standard clinical protocols |
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| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Blood Flow | On cardiac MRI, with adenosine stress, millilitres/gram/minute | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR | On cardiac MRI | 6 months |
| Rest myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global rest MBF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rasha Al-Lamee, PhD MRCP | Contact | 020 7594 5735 | r.al-lamee13@imperial.ac.uk | |
| Michael Foley, MBBS MRCP | Contact | 020 7594 5735 | m.foley@imperial.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basildon and Thurrock Hospitals NHS Foundation Trust | Not yet recruiting | Basildon | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38604209 | Derived | Foley MJ, Rajkumar CA, Ahmed-Jushuf F, Simader FA, Chotai S, Pathimagaraj RH, Mohsin M, Salih A, Wang D, Dixit P, Davies JR, Keeble TR, Cosgrove C, Spratt JC, O'Kane PD, De Silva R, Hill JM, Nijjer SS, Sen S, Petraco R, Mikhail GW, Khamis R, Kotecha T, Harrell FE, Kellman P, Francis DP, Howard JP, Cole GD, Shun-Shin MJ, Al-Lamee RK. Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial. Lancet. 2024 Apr 20;403(10436):1543-1553. doi: 10.1016/S0140-6736(24)00256-3. Epub 2024 Apr 8. | |
| 38214677 |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Placebo Procedure | Procedure | A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation |
|
On cardiac MRI, millilitres/gram/minute
| 6 months |
| Stress myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global stress MBF | On cardiac MRI, millilitres/gram/minute | 6 months |
| MPR in ischaemic segments with inferior and inferoseptal segments excluded | On cardiac MRI | 6 months |
| MBF in ischaemic segments with inferior and inferoseptal segments excluded | On cardiac MRI, millilitres/gram/minute | 6 months |
| Endocardial:epicardial ratio of stress MBF | On cardiac MRI | 6 months |
| Endocardial:epicardial ratio of rest MBF | On cardiac MRI | 6 months |
| Endocardial:epicardial ratio of MPR | On cardiac MRI | 6 months |
| Myocardial strain | On cardiac MRI | 6 months |
| Myocardial scar burden | On cardiac MRI | 6 months |
| Episodes of angina component of angina symptom score | Daily episodes recorded on ORBITA-COSMIC smartphone application | 6 months |
| Canadian Cardiovascular Society Class | On a scale from 0-4 with higher scores indicating more severe angina | 6 months |
| Angina symptom score | Derived from ORBITA-COSMIC smartphone application | 6 months |
| Seattle Angina Questionnaire (SAQ) Angina Frequency | On a scale from 0-100, with higher scores indicating better outcomes | 6 months |
| SAQ Angina Physical Limitation | On a scale from 0-100, with higher scores indicating better outcomes | 6 months |
| SAQ Quality of Life | On a scale from 0-100, with higher scores indicating better outcomes | 6 months |
| SAQ Treatment Satisfaction | On a scale from 0-100, with higher scores indicating better outcomes | 6 months |
| SAQ Angina Stability | On a scale from 0-100, with higher scores indicating better outcomes | 6 months |
| Euro-Qol (EQ-5D-5L) descriptive system | Index derived from 5 question domains, with higher scores indicating better quality of life | 6 months |
| Euro-Qol (EQ-5D-5L) visual analogue scale | Visual analogue scale from 0-100 with 100 indicating better quality of life | 6 months |
| Angina related quality of life rated by the MacNew questionnaire | On a scale from 1-7 with higher scores indicating better quality of life | 6 months |
| Treadmill Exercise Time | Modified Bruce Protocol | 6 months |
| Absolute coronary flow on pressure/temperature wire assessment | millilitres per minute | 6 months |
| Absolute coronary resistance on pressure/temperature wire assessment | mmHg/(L/min) | 6 months |
| Microvascular resistance reserve on pressure/temperature wire assessment | 6 months |
| Coronary flow reserve (CFR) on pressure/temperature wire assessment | 6 months |
| Index of microcirculatory resistance on pressure/temperature wire assessment | 6 months |
| CFR assessed by a pressure and doppler sensor wire | 6 months |
| Royal Bournemouth Hospital | Not yet recruiting | Bournemouth | United Kingdom |
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| Imperial College Healthcare NHS Trust | Recruiting | London | United Kingdom |
|
| St George's Hospital | Not yet recruiting | London | United Kingdom |
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| The Royal Brompton Hospital | Not yet recruiting | London | United Kingdom |
|
| Derived |
| Foley MJ, Rajkumar CA, Ahmed-Jushuf F, Simader F, Pathimagaraj RH, Nijjer S, Sen S, Petraco R, Clesham G, Johnson T, Harrell FE Jr, Kellman P, Francis D, Shun-Shin M, Howard J, Cole GD, Al-Lamee R. A double-blind, randomised, placebo-controlled trial of the coronary sinus Reducer in refractory angina: design and rationale of the ORBITA-COSMIC trial. EuroIntervention. 2024 Feb 5;20(3):e216-e223. doi: 10.4244/EIJ-D-23-00567. |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |