REMEDY-PILOT
Research type
Research Study
Full title
REDUCING MICROVASCULAR DYSFUNCTION IN PATIENTS WITH ANGINA, ISCHAEMIA AND UNOBSTRUCTED CORONARY ARTERIES – A PILOT STUDY (REMEDY-PILOT)
IRAS ID
295523
Contact name
Cheuk Fung Wong
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
Some patients get chest pain that feels like a heart attack but when tests are done there are no visible problems in the large arteries on the surface of the heart. This condition is called ischaemia with non-obstructed coronary arteries (INOCA). In some INOCA patients, their chest pain may be caused by a problem with the small arteries within the heart muscle, not visible to the naked eye, which under normal conditions change their size in order to control heart blood supply. If abnormal function of the small blood vessels is found, i.e. they have limited ability to open up and increase blood flow, this is termed coronary microvascular dysfunction (CMD).
We propose a study to test whether implanting a special metal device called a Coronary Sinus Reducer (CS Reducer) will improve the heart’s blood supply and improve patients’ symptoms and quality of life. The CS Reducer is safe and has been shown to help patients with other forms of chest pain. It is thought that the CS Reducer, which narrows the main outlet vein of the heart, will back up blood so that more blood is then available to be re-directed to areas where there is not enough. With more blood reaching the affected areas with reduced blood supply, it is hoped that the frequency and severity of chest pain will reduce, leading to improved quality of life.
Our study will be the first to test whether implanting the CS Reducer can improve blood supply and reduce chest pain in patients with INOCA and CMD. This initial pilot study will examine if:
i) we are able to recruit enough participants
ii) CS Reducer implantation is an acceptable procedure for participants
iii) CS Reducer implantation can improve blood flow to the heart tested on cardiac MRI and at coronary angiography.REC name
Scotland B REC
REC reference
22/SS/0014
Date of REC Opinion
29 Apr 2022
REC opinion
Further Information Favourable Opinion