ORBITA-COSMIC: Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance

• Sponsor: Imperial College London (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04892537
• Collaborator: Medical Research Council (Other)
• Enrollment: 40
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 31.4
• Patients Per Site: 8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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 40 participants with refractory angina and ischaemia.

Condition or Disease	Intervention/Treatment	Phase
Refractory Angina	Device: Coronary Sinus Reducer; Procedure: Placebo Procedure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
• Actual Study Start Date: May 21, 2021
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CSR Coronary Sinus Reducer implantation	Device: Coronary Sinus Reducer; Coronary Sinus Reducer implantation according to standard clinical protocols; Other Names: CSR
Placebo Comparator: Placebo Placebo procedure	Procedure: Placebo Procedure; A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation

Outcome Measures

Primary Outcome Measures

1. Change in Myocardial Perfusion Reserve on MRI between the groups [6 months]

Secondary Outcome Measures

1. Change in coronary resistance on pressure/temperature wire assessment between the groups [6 months]

2. Change in absolute coronary flow on pressure/temperature wire assessment between the groups [6 months]

3. Change in treadmill exercise time between the groups [6 months]

4. Change in angina frequency recorded on a smartphone symptom application between the groups [6 months]

5. Change in physical limitation as assessed with the Seattle Angina Questionnaire between the groups [6 months]

   On a scale from 0-100, with higher scores indicating better outcomes

6. Change in angina stability as assessed with the Seattle Angina Questionnaire between the groups [6 months]

   On a scale from 0-100, with higher scores indicating better outcomes

7. Change in quality of life as assessed with the Seattle Angina Questionnaire between the groups [6 months]

   On a scale from 0-100, with higher scores indicating better outcomes

8. Change in angina frequency as assessed with the Seattle Angina Questionnaire between the groups [6 months]

   On a scale from 0-100, with higher scores indicating better outcomes

9. Change in freedom from angina as assessed with the Seattle Angina Questionnaire between the groups [6 months]

   Binary outcome

10. Change in quality of life as assessed with the EQ-5D-5L questionnaire visual analogue scale between the groups [6 months]

    Visual analogue scale from 0-100 with 100 indicating better quality of life

11. Change in quality of life health state index as assessed with the EQ-5D-5L questionnaire between the groups [6 months]

    Index derived from 5 question domains, with higher scores indicating better quality of life

12. Change in health related quality of life as assessed with the MacNew questionnaire between the groups [6 months]

    On a scale from 1-7 with higher scores indicating better quality of life

13. Change in Canadian Cardiovascular Society (CCS) Class between the groups [6 months]

    On a scale from 0-4 with higher score indicating more severe angina

14. Change in average daily steps measured on a smartwatch between the groups [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Basildon and Thurrock Hospitals NHS Foundation Trust	Basildon		United Kingdom
2	Royal Bournemouth Hospital	Bournemouth		United Kingdom
3	Imperial College Healthcare NHS Trust	London		United Kingdom
4	St George's Hospital	London		United Kingdom
5	The Royal Brompton Hospital	London		United Kingdom

Sponsors and Collaborators

• Imperial College London
• Medical Research Council

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT04892537
• Other Study ID Numbers: 20HH6457; MR/V001620/1
• First Posted: May 19, 2021
• Last Update Posted: Aug 31, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ischemia

Study Results

No Results Posted as of Aug 31, 2021