Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
NCT ID: NCT04892537
Last Updated: 2023-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-05-21
2024-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
NCT05459051
CORonary MICrovascular Angina (CorMicA)
NCT03193294
The ORCHESTRATE-Myocarditis Registry
NCT05139329
Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease
NCT02783963
Mechanisms Behind Microvascular Dysfunction in INOCA
NCT06529861
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CSR
Coronary Sinus Reducer implantation
Coronary Sinus Reducer
Coronary Sinus Reducer implantation according to standard clinical protocols
Placebo
Placebo procedure
Placebo Procedure
A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Coronary Sinus Reducer
Coronary Sinus Reducer implantation according to standard clinical protocols
Placebo Procedure
A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Evidence of ischaemia on stress perfusion CMR
* Angina - Canadian Cardiovascular Society Class II-VI on maximal medical therapy
Exclusion Criteria
* Pregnancy
* Inability to consent
* Recent acute coronary syndrome (3 months)
* Recent revascularisation (6 months)
* Permanent pacemaker or defibrillator leads in the right heart
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical Research Council
OTHER_GOV
Imperial College Healthcare Nissen Fund
UNKNOWN
Imperial College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Basildon and Thurrock Hospitals NHS Foundation Trust
Basildon, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
St George's Hospital
London, , United Kingdom
The Royal Brompton Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MR/V001620/1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20HH6457
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.