Actively Recruiting
REducing Microvascular Dysfunction in Patients With Angina, Ischaemia and unobstructED coronarY Arteries - a PILOT Study
Led by Imperial College London · Updated on 2025-04-03
54
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
B
Bradford Teaching Hospitals NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with ischaemia and non-obstructed coronary arteries (INOCA) who experience symptoms of angina linked to coronary microvascular dysfunction (CMD). This research aims to assess the Coronary Sinus Reducer (CS Reducer) device as a treatment to improve blood flow in the heart's small vessels. The trial includes a nested mechanistic substudy to explore how the device changes coronary microcirculation and affects heart muscle blood flow, symptoms, and quality of life. The trial compares two groups: one receiving the CS Reducer device implanted into the coronary sinus, and a control group undergoing a sham procedure without device implantation. The CS Reducer is a stainless steel device designed to create a narrowing in the coronary sinus to redistribute blood flow. Participants will be randomly assigned and neither they nor the researchers will know which procedure was performed. The substudy involves invasive coronary physiology assessments to understand the device's effects on heart microcirculation. Participants will be involved for six months, during which they will undergo assessments including myocardial perfusion imaging, angina symptom scores, quality of life questionnaires, exercise tests, and safety monitoring. Researchers will track the number of participants who consent and remain in the study, changes in myocardial perfusion, angina severity, and any major adverse events. The study aims to confirm the feasibility of the device implantation and its potential impact on blood flow and symptoms in this patient group.
CONDITIONS
Brief Title
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Ongoing symptomatic angina, Canadian Cardiovascular Society (CCS) Class II-IV, for at least 3 months despite treatment with at least two anti-anginal drugs at maximal tolerated doses
- Willing to keep anti-anginal drug treatment unchanged during the trial
- Unobstructed coronary arteries with 50% or less stenosis shown by coronary angiography
- Stress-induced reduced blood flow on cardiac magnetic resonance imaging (CMR) with Global Myocardial Perfusion Reserve (MPR) of 2.2 or less
- Willing to comply with follow-up evaluations and be contactable during the trial
- Understands the trial procedures and provides written informed consent
You will not qualify if you...
- Significant coronary artery disease with stenosis over 50%, coronary artery bypass grafting, or prior myocardial infarction
- Percutaneous coronary intervention (PCI) within 6 months
- PCI with stent for acute myocardial infarction or chronic total occlusion
- Abnormal coronary sinus anatomy preventing device implantation
- Coronary sinus diameter unsuitable for device (less than 9.5mm or greater than 13mm)
- Mean right atrial pressure below 15mmHg at implantation
- Structural heart disease including left ventricular hypertrophy, cardiomyopathy, severe valvular disease, previous valve replacement, myocardial bridge, or left ventricular ejection fraction below 45%
- Coronary vasospasm diagnosed clinically or angiographically
- Previous hospitalization for decompensated heart failure
- Presence of pacemaker or defibrillator leads in the right atrium, right ventricle, or coronary sinus
- Documented arrhythmia requiring pacemaker or defibrillator implantation
- Chronic kidney disease with creatinine over 200 micromol/L or on renal replacement therapy
- Hemoglobin below 80 g/L
- Contraindications to dual antiplatelet therapy
- Severe chronic obstructive pulmonary disease with FEV1 below 55% predicted
- Life expectancy less than 1 year
- Known allergy to nickel or steel
- Current participation in another investigational device or drug trial
- Contraindications to cardiac magnetic resonance imaging or intravenous adenosine
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of implantation
Participants undergo implantation of the Coronary Sinus Reducer device or a sham procedure as part of the trial intervention.
1 visit (in-person)
Duration - 6 months
Participants are monitored for safety, symptom changes, and myocardial perfusion over 6 months following the implantation.
Multiple visits over 6 months for assessments including imaging, symptom questionnaires, and physical tests
Trial Site Locations
Total: 1 location
1
National Heart and Lung Institute (Brompton Campus), Imperial College London
London, United Kingdom, SW36NP
Actively Recruiting
Research Team
R
Ranil de Silva, FRCP, PhD
K
Kevin Cheng, BM BCh, MRCP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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