Implanting a device to improve blood flow in patients with angina and no blocked arteries
REducing Microvascular Dysfunction in Patients With Angina, Ischaemia and unobstructED coronarY Arteries - a PILOT Study
This study is testing a new device to see if it can help people with angina and no blocked arteries feel better by improving blood flow to their heart.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05492110 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and effectiveness of the Coronary Sinus Reducer for treating patients suffering from ischaemia and non-obstructed coronary arteries, specifically those with coronary microvascular dysfunction. It will involve a randomized, double-blinded, sham-controlled pilot approach to assess the acceptability of the device implantation and its impact on myocardial perfusion. Additionally, a nested mechanistic substudy will investigate the physiological changes in the coronary microcirculation that may explain improvements in symptoms and quality of life. The study seeks to address a significant unmet clinical need for patients with refractory angina.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with ongoing symptomatic angina for at least three months despite maximum tolerated doses of two anti-anginal medications.
Not a fit: Patients with significant epicardial coronary artery disease or those who have had recent coronary interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms and improve quality of life for patients with refractory angina.
How similar studies have performed: While the approach of using a Coronary Sinus Reducer is novel, similar studies targeting coronary microvascular dysfunction have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>18 years 2. Ongoing symptomatic angina, CCS Class II-IV, for ≥3 months despite background treatment with at least two anti-anginal drug at the maximal tolerated dose. 3. Patients willing to consider no change in anti-anginal drug treatment for the duration of their participation in the trial. 4. Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated on coronary angiography. 5. Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2). 6. Willingness to comply with the specified follow-up evaluation and to be contactable during the period of the trial. 7. Understands the nature of the trial procedures and provides written informed consent. Exclusion Criteria: 1. Epicardial CAD in a main coronary artery (stenoses \>50%, RFR≤0.92 or FFR≤0.80), coronary artery bypass grafting, or myocardial infarction (MI). 2. Previous PCI within 6 months 3. PCI with stent insertion for acute MI or chronic total occlusion (CTO) 4. Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent left superior vena cava) 5. Coronary sinus diameter at site of implant \<9.5mm or \>13mm 6. Mean right atrial pressure \<15mmHg at time of implantation 7. Any structural heart disease including left ventricular hypertrophy; cardiomyopathy; severe valvular heart disease; previous valve replacement; myocardial bridge on angiography; LVEF\<45% by CMR. 8. Clinically or angiographically diagnosed coronary vasospasm 9. Previous hospitalisation for decompensated heart failure 10. Pacemaker or defibrillator electrode in the right atrium, right ventricle or coronary sinus 11. Documented arrhythmia requiring planned implantation of a permanent pacemaker or defibrillator 12. Chronic kidney disease (creatinine \>200 micromol/L; established on renal replacement therapy; functioning renal transplant) 13. Haemoglobin \<80g/L 14. Contraindications to receiving dual antiplatelet therapy 15. Severe chronic obstructive pulmonary disease (FEV1 \<55% predicted) 16. Moribund patients with life expectancy \< 1year 17. Known allergy to nickel or steel 18. Current enrolment in another investigational device or drug trial 19. Contraindications to CMR or receiving intravenous adenosine 20. Pregnancy
Where this trial is running
London
- National Heart and Lung Institute (Brompton Campus), Imperial College London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ranil E de Silva, FRCP, PhD — Imperial College London
- Study coordinator: Ranil de Silva, FRCP, PhD
- Email: r.desilva@imperial.ac.uk
- Phone: +44 2073518626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.