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

Refractory Angina Clinical Trial

— ORBITA-COSMIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892537
• Other study ID #: 20HH6457
• Secondary ID: MR/V001620/1
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: January 2024

Study information

• Verified date: October 2023
• Source: Imperial College London
• Contact: Rasha Al-Lamee, PhD MRCP
• Phone: 020 7594 5735
• Email: r.al-lamee13[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Refractory Angina

Intervention

Device:
• Coronary Sinus Reducer
Coronary Sinus Reducer implantation according to standard clinical protocols

Procedure:
• Placebo Procedure
A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare Nissen Fund, Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Blood Flow	On cardiac MRI, with adenosine stress, millilitres/gram/minute	6 months
Secondary	Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR	On cardiac MRI	6 months
Secondary	Rest myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global rest MBF	On cardiac MRI, millilitres/gram/minute	6 months
Secondary	Stress myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global stress MBF	On cardiac MRI, millilitres/gram/minute	6 months
Secondary	MPR in ischaemic segments with inferior and inferoseptal segments excluded	On cardiac MRI	6 months
Secondary	MBF in ischaemic segments with inferior and inferoseptal segments excluded	On cardiac MRI, millilitres/gram/minute	6 months
Secondary	Endocardial:epicardial ratio of stress MBF	On cardiac MRI	6 months
Secondary	Endocardial:epicardial ratio of rest MBF	On cardiac MRI	6 months
Secondary	Endocardial:epicardial ratio of MPR	On cardiac MRI	6 months
Secondary	Myocardial strain	On cardiac MRI	6 months
Secondary	Myocardial scar burden	On cardiac MRI	6 months
Secondary	Episodes of angina component of angina symptom score	Daily episodes recorded on ORBITA-COSMIC smartphone application	6 months
Secondary	Canadian Cardiovascular Society Class	On a scale from 0-4 with higher scores indicating more severe angina	6 months
Secondary	Angina symptom score	Derived from ORBITA-COSMIC smartphone application	6 months
Secondary	Seattle Angina Questionnaire (SAQ) Angina Frequency	On a scale from 0-100, with higher scores indicating better outcomes	6 months
Secondary	SAQ Angina Physical Limitation	On a scale from 0-100, with higher scores indicating better outcomes	6 months
Secondary	SAQ Quality of Life	On a scale from 0-100, with higher scores indicating better outcomes	6 months
Secondary	SAQ Treatment Satisfaction	On a scale from 0-100, with higher scores indicating better outcomes	6 months
Secondary	SAQ Angina Stability	On a scale from 0-100, with higher scores indicating better outcomes	6 months
Secondary	Euro-Qol (EQ-5D-5L) descriptive system	Index derived from 5 question domains, with higher scores indicating better quality of life	6 months
Secondary	Euro-Qol (EQ-5D-5L) visual analogue scale	Visual analogue scale from 0-100 with 100 indicating better quality of life	6 months
Secondary	Angina related quality of life rated by the MacNew questionnaire	On a scale from 1-7 with higher scores indicating better quality of life	6 months
Secondary	Treadmill Exercise Time	Modified Bruce Protocol	6 months
Secondary	Absolute coronary flow on pressure/temperature wire assessment	millilitres per minute	6 months
Secondary	Absolute coronary resistance on pressure/temperature wire assessment	mmHg/(L/min)	6 months
Secondary	Microvascular resistance reserve on pressure/temperature wire assessment		6 months
Secondary	Coronary flow reserve (CFR) on pressure/temperature wire assessment		6 months
Secondary	Index of microcirculatory resistance on pressure/temperature wire assessment		6 months
Secondary	CFR assessed by a pressure and doppler sensor wire		6 months