Refractory AnginaORBITA-COSMICNCT04892537
Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
A study testing Coronary Sinus Reducer in people with Refractory Angina, run by Imperial College London at 5 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Angina
- What is being tested?
- Coronary Sinus Reducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 21 May 2021to Jan 2024
- 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
- Stable coronary artery disease (CAD) not eligible for percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG)
- Evidence of ischaemia on stress perfusion CMR
- Angina - Canadian Cardiovascular Society Class II-VI on maximal medical therapy
Who cannot join
- Age<18 years
- Pregnancy
- Inability to consent
- Recent acute coronary syndrome (3 months)
- Recent revascularisation (6 months)
- Permanent pacemaker or defibrillator leads in the right heart
Show all 15Show fewer
- Severe left ventricular impairment (<25%)
- Indication for cardiac resynchronisation therapy (CRT)
- Right atrial pressure ≥15mmHg
- Life expectancy <1 year
- Severe renal impairment (eGFR<15)
- Contraindication to CMR
- Contraindication to adenosine
- Ischaemia isolated to inferior wall
- Ongoing participation in a separate interventional study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
Basildon and Thurrock Hospitals NHS Foundation Trust
Basildon
John Davies, PhD, john.davies@btuh.nhs.uk
- Not yet recruiting
Royal Bournemouth Hospital
Bournemouth
Peter O'Kane, peter.o'kane@rbch.nhs.uk
- Recruiting
Imperial College Healthcare NHS Trust
London
Rasha Al-Lamee, PhD MRCP, 02075945735, rasha.al-lamee@nhs.net
Michael Foley, MBBS MRCP, 02075945735, m.foley@nhs.net
- Not yet recruiting
St George's Hospital
London
James Spratt, MbChB MD, james.spratt@nhs.net
- Not yet recruiting
The Royal Brompton Hospital
London
Jonathan Hill, jmhill@nhs.net
About this study
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.
- Conditions
- Refractory Angina
- Being tested
- Coronary Sinus Reducer, Placebo Procedure
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Sinus ReducerDevice
Also called CSR
Coronary Sinus Reducer implantation according to standard clinical protocols
Placebo ProcedureProcedure or surgery
A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation
| Study group | Role | What they receive |
|---|---|---|
| CSR | Active comparator | Coronary Sinus Reducer implantation Receives: Device: Coronary Sinus Reducer |
| Placebo | Placebo comparator | Placebo procedure Receives: Procedure: Placebo Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Blood Flow
On cardiac MRI, with adenosine stress, millilitres/gram/minute
Measured: 6 months
Secondary outcomes (28)
Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR
On cardiac MRI
Measured: 6 months
Rest myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global rest MBF
On cardiac MRI, millilitres/gram/minute
Measured: 6 months
Stress myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global stress MBF
On cardiac MRI, millilitres/gram/minute
Measured: 6 months
MPR in ischaemic segments with inferior and inferoseptal segments excluded
On cardiac MRI
Measured: 6 months
MBF in ischaemic segments with inferior and inferoseptal segments excluded
On cardiac MRI, millilitres/gram/minute
Measured: 6 months
Endocardial:epicardial ratio of stress MBF
On cardiac MRI
Measured: 6 months
Endocardial:epicardial ratio of rest MBF
On cardiac MRI
Measured: 6 months
Endocardial:epicardial ratio of MPR
On cardiac MRI
Measured: 6 months
Myocardial strain
On cardiac MRI
Measured: 6 months
Myocardial scar burden
On cardiac MRI
Measured: 6 months
Episodes of angina component of angina symptom score
Daily episodes recorded on ORBITA-COSMIC smartphone application
Measured: 6 months
Canadian Cardiovascular Society Class
On a scale from 0-4 with higher scores indicating more severe angina
Measured: 6 months
Angina symptom score
Derived from ORBITA-COSMIC smartphone application
Measured: 6 months
Seattle Angina Questionnaire (SAQ) Angina Frequency
On a scale from 0-100, with higher scores indicating better outcomes
Measured: 6 months
SAQ Angina Physical Limitation
On a scale from 0-100, with higher scores indicating better outcomes
Measured: 6 months
SAQ Quality of Life
On a scale from 0-100, with higher scores indicating better outcomes
Measured: 6 months
SAQ Treatment Satisfaction
On a scale from 0-100, with higher scores indicating better outcomes
Measured: 6 months
SAQ Angina Stability
On a scale from 0-100, with higher scores indicating better outcomes
Measured: 6 months
Euro-Qol (EQ-5D-5L) descriptive system
Index derived from 5 question domains, with higher scores indicating better quality of life
Measured: 6 months
Euro-Qol (EQ-5D-5L) visual analogue scale
Visual analogue scale from 0-100 with 100 indicating better quality of life
Measured: 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
Measured: 6 months
Treadmill Exercise Time
Modified Bruce Protocol
Measured: 6 months
Absolute coronary flow on pressure/temperature wire assessment
millilitres per minute
Measured: 6 months
Absolute coronary resistance on pressure/temperature wire assessment
mmHg/(L/min)
Measured: 6 months
Microvascular resistance reserve on pressure/temperature wire assessment
Measured: 6 months
Coronary flow reserve (CFR) on pressure/temperature wire assessment
Measured: 6 months
Index of microcirculatory resistance on pressure/temperature wire assessment
Measured: 6 months
CFR assessed by a pressure and doppler sensor wire
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 posted19 May 2021
- Study start21 May 2021
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refractory AnginaStudies of the same condition, open and under way.
- More trials run by Imperial 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Imperial College Healthcare Nissen Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892537
- Sponsor's protocol ID
- 20HH6457
- Other IDs
- MR/V001620/1
- Acronym
- ORBITA-COSMIC
- Status last verified
- Oct 2023
- First submitted
- 30 Apr 2021
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38604209Foley 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.
PubMed 38214677
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
- ClinicalTrials.gov ID
- NCT04892537
- Acronym / sponsor ID
- ORBITA-COSMIC / 20HH6457
- Conditions
- Refractory Angina
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, Imperial College Healthcare Nissen Fund
- Study start
- 21 May 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 19 May 2021 (actual)
- 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.
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.
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 |
|---|---|---|
| CSR | Active comparator | Device: Coronary Sinus ReducerCoronary Sinus Reducer implantation |
| Placebo | Placebo comparator | Procedure: Placebo ProcedurePlacebo procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable coronary artery disease (CAD) not eligible for percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG)
- Evidence of ischaemia on stress perfusion CMR
- Angina - Canadian Cardiovascular Society Class II-VI on maximal medical therapy
Key exclusion criteria (15 listed)
- Age<18 years
- Pregnancy
- Inability to consent
- Recent acute coronary syndrome (3 months)
- Recent revascularisation (6 months)
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 |
|---|---|---|
| Coronary Sinus ReducerAlso: CSRCoronary Sinus Reducer implantation according to standard clinical protocols | Device | CSR |
| Placebo ProcedureA placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation | Procedure or surgery | Placebo |
Primary outcome
Myocardial Blood Flow
Time frame: 6 months
On cardiac MRI, with adenosine stress, millilitres/gram/minute
28 secondary outcomes
Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR
Time frame: 6 months
Rest myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global rest MBF
Time frame: 6 months
Stress myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global stress MBF
Time frame: 6 months
MPR in ischaemic segments with inferior and inferoseptal segments excluded
Time frame: 6 months
MBF in ischaemic segments with inferior and inferoseptal segments excluded
Time frame: 6 months
Endocardial:epicardial ratio of stress MBF
Time frame: 6 months
Endocardial:epicardial ratio of rest MBF
Time frame: 6 months
Endocardial:epicardial ratio of MPR
Time frame: 6 months
Myocardial strain
Time frame: 6 months
Myocardial scar burden
Time frame: 6 months
Episodes of angina component of angina symptom score
Time frame: 6 months
Canadian Cardiovascular Society Class
Time frame: 6 months
Angina symptom score
Time frame: 6 months
Seattle Angina Questionnaire (SAQ) Angina Frequency
Time frame: 6 months
SAQ Angina Physical Limitation
Time frame: 6 months
SAQ Quality of Life
Time frame: 6 months
SAQ Treatment Satisfaction
Time frame: 6 months
SAQ Angina Stability
Time frame: 6 months
Euro-Qol (EQ-5D-5L) descriptive system
Time frame: 6 months
Euro-Qol (EQ-5D-5L) visual analogue scale
Time frame: 6 months
Angina related quality of life rated by the MacNew questionnaire
Time frame: 6 months
Treadmill Exercise Time
Time frame: 6 months
Absolute coronary flow on pressure/temperature wire assessment
Time frame: 6 months
Absolute coronary resistance on pressure/temperature wire assessment
Time frame: 6 months
Microvascular resistance reserve on pressure/temperature wire assessment
Time frame: 6 months
Coronary flow reserve (CFR) on pressure/temperature wire assessment
Time frame: 6 months
Index of microcirculatory resistance on pressure/temperature wire assessment
Time frame: 6 months
CFR assessed by a pressure and doppler sensor wire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 38604209Foley 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.
- Derived from this study: PubMed 38214677Foley 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.
Related trials for Refractory Angina
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
Recruiting
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
Refractory Angina
RecruitingPhase 2
Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.
Refractory Angina, Coronary Artery Disease
Active, not recruiting
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
Refractory Angina, Microvascular Angina
Not yet recruiting
Coronary Sinus Reducer Therapy for Persisting Angina
Coronary Artery Disease, Angina (Stable)
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Sinus Reducer in people with Refractory Angina, run by Imperial College London at 5 sites in United Kingdom.
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 15 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rasha Al-Lamee, PhD MRCP (020 7594 5735, r.al-lamee13@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Blood Flow (time frame: 6 months). 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 NCT04892537, which also lists 2 linked publications.
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 30 Oct 2023.