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

October 26, 2023 updated by: Imperial College London
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Basildon, United Kingdom
        • Not yet recruiting
        • Basildon and Thurrock Hospitals NHS Foundation Trust
        • Contact:
      • Bournemouth, United Kingdom
      • London, United Kingdom
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
        • Contact:
          • Michael Foley, MBBS MRCP
          • Phone Number: 02075945735
          • Email: m.foley@nhs.net
      • London, United Kingdom
        • Not yet recruiting
        • St George's Hospital
        • Contact:
      • London, United Kingdom
        • Not yet recruiting
        • The Royal Brompton Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Active Comparator: CSR
Coronary Sinus Reducer implantation
Device: Coronary Sinus Reducer
Coronary Sinus Reducer implantation according to standard clinical protocols
Other Names:
  • CSR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Myocardial Blood Flow
Time Frame: 6 months
On cardiac MRI, with adenosine stress, millilitres/gram/minute
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR
Time Frame: 6 months
On cardiac MRI
6 months
Rest myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global rest MBF
Time Frame: 6 months
On cardiac MRI, millilitres/gram/minute
6 months
Stress myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global stress MBF
Time Frame: 6 months
On cardiac MRI, millilitres/gram/minute
6 months
MPR in ischaemic segments with inferior and inferoseptal segments excluded
Time Frame: 6 months
On cardiac MRI
6 months
MBF in ischaemic segments with inferior and inferoseptal segments excluded
Time Frame: 6 months
On cardiac MRI, millilitres/gram/minute
6 months
Endocardial:epicardial ratio of stress MBF
Time Frame: 6 months
On cardiac MRI
6 months
Endocardial:epicardial ratio of rest MBF
Time Frame: 6 months
On cardiac MRI
6 months
Endocardial:epicardial ratio of MPR
Time Frame: 6 months
On cardiac MRI
6 months
Myocardial strain
Time Frame: 6 months
On cardiac MRI
6 months
Myocardial scar burden
Time Frame: 6 months
On cardiac MRI
6 months
Episodes of angina component of angina symptom score
Time Frame: 6 months
Daily episodes recorded on ORBITA-COSMIC smartphone application
6 months
Canadian Cardiovascular Society Class
Time Frame: 6 months
On a scale from 0-4 with higher scores indicating more severe angina
6 months
Angina symptom score
Time Frame: 6 months
Derived from ORBITA-COSMIC smartphone application
6 months
Seattle Angina Questionnaire (SAQ) Angina Frequency
Time Frame: 6 months
On a scale from 0-100, with higher scores indicating better outcomes
6 months
SAQ Angina Physical Limitation
Time Frame: 6 months
On a scale from 0-100, with higher scores indicating better outcomes
6 months
SAQ Quality of Life
Time Frame: 6 months
On a scale from 0-100, with higher scores indicating better outcomes
6 months
SAQ Treatment Satisfaction
Time Frame: 6 months
On a scale from 0-100, with higher scores indicating better outcomes
6 months
SAQ Angina Stability
Time Frame: 6 months
On a scale from 0-100, with higher scores indicating better outcomes
6 months
Euro-Qol (EQ-5D-5L) descriptive system
Time Frame: 6 months
Index derived from 5 question domains, with higher scores indicating better quality of life
6 months
Euro-Qol (EQ-5D-5L) visual analogue scale
Time Frame: 6 months
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
Time Frame: 6 months
On a scale from 1-7 with higher scores indicating better quality of life
6 months
Treadmill Exercise Time
Time Frame: 6 months
Modified Bruce Protocol
6 months
Absolute coronary flow on pressure/temperature wire assessment
Time Frame: 6 months
millilitres per minute
6 months
Absolute coronary resistance on pressure/temperature wire assessment
Time Frame: 6 months
mmHg/(L/min)
6 months
Microvascular resistance reserve on pressure/temperature wire assessment
Time Frame: 6 months
6 months
Coronary flow reserve (CFR) on pressure/temperature wire assessment
Time Frame: 6 months
6 months
Index of microcirculatory resistance on pressure/temperature wire assessment
Time Frame: 6 months
6 months
CFR assessed by a pressure and doppler sensor wire
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Research Council
Imperial College Healthcare Nissen Fund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20HH6457
  • MR/V001620/1 (Other Grant/Funding Number: Medical Research Council)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings