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

Primary Purpose

Refractory Angina

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Coronary Sinus Reducer
Placebo Procedure
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Angina

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Basildon and Thurrock Hospitals NHS Foundation Trust
  • Royal Bournemouth Hospital
  • Imperial College Healthcare NHS TrustRecruiting
  • St George's Hospital
  • The Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CSR

Placebo

Arm Description

Coronary Sinus Reducer implantation

Placebo procedure

Outcomes

Primary Outcome Measures

Change in Myocardial Blood Flow on MRI between the groups

Secondary Outcome Measures

Change in coronary resistance on pressure/temperature wire assessment between the groups
Change in absolute coronary flow on pressure/temperature wire assessment between the groups
Change in treadmill exercise time between the groups
Change in angina frequency recorded on a smartphone symptom application between the groups
Change in physical limitation as assessed with the Seattle Angina Questionnaire between the groups
On a scale from 0-100, with higher scores indicating better outcomes
Change in angina stability as assessed with the Seattle Angina Questionnaire between the groups
On a scale from 0-100, with higher scores indicating better outcomes
Change in quality of life as assessed with the Seattle Angina Questionnaire between the groups
On a scale from 0-100, with higher scores indicating better outcomes
Change in angina frequency as assessed with the Seattle Angina Questionnaire between the groups
On a scale from 0-100, with higher scores indicating better outcomes
Change in freedom from angina as assessed with the Seattle Angina Questionnaire between the groups
Binary outcome
Change in quality of life as assessed with the EQ-5D-5L questionnaire visual analogue scale between the groups
Visual analogue scale from 0-100 with 100 indicating better quality of life
Change in quality of life health state index as assessed with the EQ-5D-5L questionnaire between the groups
Index derived from 5 question domains, with higher scores indicating better quality of life
Change in health related quality of life as assessed with the MacNew questionnaire between the groups
On a scale from 1-7 with higher scores indicating better quality of life
Change in Canadian Cardiovascular Society (CCS) Class between the groups
On a scale from 0-4 with higher score indicating more severe angina
Change in average daily steps measured on a smartwatch between the groups

Full Information

First Posted
April 30, 2021
Last Updated
July 14, 2023
Sponsor
Imperial College London
Collaborators
Medical Research Council, Imperial College Healthcare Nissen Fund
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1. Study Identification

Unique Protocol Identification Number
NCT04892537
Brief Title
Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
Acronym
ORBITA-COSMIC
Official Title
Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Medical Research Council, Imperial College Healthcare Nissen Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 50 participants with refractory angina and ischaemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CSR
Arm Type
Active Comparator
Arm Description
Coronary Sinus Reducer implantation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo procedure
Intervention Type
Device
Intervention Name(s)
Coronary Sinus Reducer
Other Intervention Name(s)
CSR
Intervention Description
Coronary Sinus Reducer implantation according to standard clinical protocols
Intervention Type
Procedure
Intervention Name(s)
Placebo Procedure
Intervention Description
A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation
Primary Outcome Measure Information:
Title
Change in Myocardial Blood Flow on MRI between the groups
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in coronary resistance on pressure/temperature wire assessment between the groups
Time Frame
6 months
Title
Change in absolute coronary flow on pressure/temperature wire assessment between the groups
Time Frame
6 months
Title
Change in treadmill exercise time between the groups
Time Frame
6 months
Title
Change in angina frequency recorded on a smartphone symptom application between the groups
Time Frame
6 months
Title
Change in physical limitation as assessed with the Seattle Angina Questionnaire between the groups
Description
On a scale from 0-100, with higher scores indicating better outcomes
Time Frame
6 months
Title
Change in angina stability as assessed with the Seattle Angina Questionnaire between the groups
Description
On a scale from 0-100, with higher scores indicating better outcomes
Time Frame
6 months
Title
Change in quality of life as assessed with the Seattle Angina Questionnaire between the groups
Description
On a scale from 0-100, with higher scores indicating better outcomes
Time Frame
6 months
Title
Change in angina frequency as assessed with the Seattle Angina Questionnaire between the groups
Description
On a scale from 0-100, with higher scores indicating better outcomes
Time Frame
6 months
Title
Change in freedom from angina as assessed with the Seattle Angina Questionnaire between the groups
Description
Binary outcome
Time Frame
6 months
Title
Change in quality of life as assessed with the EQ-5D-5L questionnaire visual analogue scale between the groups
Description
Visual analogue scale from 0-100 with 100 indicating better quality of life
Time Frame
6 months
Title
Change in quality of life health state index as assessed with the EQ-5D-5L questionnaire between the groups
Description
Index derived from 5 question domains, with higher scores indicating better quality of life
Time Frame
6 months
Title
Change in health related quality of life as assessed with the MacNew questionnaire between the groups
Description
On a scale from 1-7 with higher scores indicating better quality of life
Time Frame
6 months
Title
Change in Canadian Cardiovascular Society (CCS) Class between the groups
Description
On a scale from 0-4 with higher score indicating more severe angina
Time Frame
6 months
Title
Change in average daily steps measured on a smartwatch between the groups
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rasha Al-Lamee, PhD MRCP
Phone
020 7594 5735
Email
r.al-lamee13@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Foley, MBBS MRCP
Phone
020 7594 5735
Email
m.foley@imperial.ac.uk
Facility Information:
Facility Name
Basildon and Thurrock Hospitals NHS Foundation Trust
City
Basildon
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Davies, PhD
Email
john.davies@btuh.nhs.uk
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter O'Kane
Email
peter.o'kane@rbch.nhs.uk
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasha Al-Lamee, PhD MRCP
Phone
02075945735
Email
rasha.al-lamee@nhs.net
First Name & Middle Initial & Last Name & Degree
Michael Foley, MBBS MRCP
Phone
02075945735
Email
m.foley@nhs.net
Facility Name
St George's Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Spratt, MbChB MD
Email
james.spratt@nhs.net
Facility Name
The Royal Brompton Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Hill
Email
jmhill@nhs.net

12. IPD Sharing Statement

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Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance

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