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

Imperial College London50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Refractory Angina

Interventions

Coronary Sinus ReducerDEVICE

Coronary Sinus Reducer implantation according to standard clinical protocols

Placebo ProcedurePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Basildon and Thurrock Hospitals NHS Foundation Trust

Basildon, United Kingdom

NOT_YET_RECRUITING

Royal Bournemouth Hospital

Bournemouth, United Kingdom

NOT_YET_RECRUITING

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Myocardial Blood Flow

On cardiac MRI, with adenosine stress, millilitres/gram/minute

Time frame: 6 months

Secondary Outcomes

Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR

On cardiac MRI

Time frame: 6 months

Rest myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global rest MBF

On cardiac MRI, millilitres/gram/minute

Time frame: 6 months

Stress myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global stress MBF

On cardiac MRI, millilitres/gram/minute

Time frame: 6 months

MPR in ischaemic segments with inferior and inferoseptal segments excluded

On cardiac MRI

Time frame: 6 months

MBF in ischaemic segments with inferior and inferoseptal segments excluded

On cardiac MRI, millilitres/gram/minute

Time frame: 6 months

Endocardial:epicardial ratio of stress MBF

On cardiac MRI

Time frame: 6 months

Endocardial:epicardial ratio of rest MBF

On cardiac MRI

Time frame: 6 months

Endocardial:epicardial ratio of MPR

Central Contacts

Rasha Al-Lamee, PhD MRCP

CONTACT

020 7594 5735 r.al-lamee13@imperial.ac.uk

Michael Foley, MBBS MRCP

CONTACT

020 7594 5735 m.foley@imperial.ac.uk

Data from ClinicalTrials.gov

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