A double-blind, randomised, placebo-controlled trial of the coronary sinus Reducer in refractory angina: design and rationale of the ORBITA-COSMIC trial.

Autor:	Foley MJ; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom., Rajkumar CA; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom., Ahmed-Jushuf F; National Heart and Lung Institute, Imperial College London, London, United Kingdom., Simader F; National Heart and Lung Institute, Imperial College London, London, United Kingdom., Pathimagaraj RH; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom., Nijjer S; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom., Sen S; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom., Petraco R; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom., Clesham G; Essex Cardiothoracic Centre, Basildon, United Kingdom., Johnson T; Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom., Harrell FE Jr; Vanderbilt University School of Medicine, Nashville, TN, USA., Kellman P; National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA., Francis D; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom., Shun-Shin M; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom., Howard J; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom., Cole GD; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom., Al-Lamee R; National Heart and Lung Institute, Imperial College London, London, United Kingdom.; Imperial College Healthcare NHS Trust, London, United Kingdom.
Jazyk:	angličtina
Zdroj:	EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology [EuroIntervention] 2024 Feb 05; Vol. 20 (3), pp. e216-e223. Date of Electronic Publication: 2024 Feb 05.
DOI:	10.4244/EIJ-D-23-00567
Abstrakt:	The coronary sinus Reducer (CSR) is an hourglass-shaped device which creates an artificial stenosis in the coronary sinus. Whilst placebo-controlled data show an improvement in angina, these results are unreplicated and are the subject of further confirmatory research. The mechanism of action of this unintuitive therapy is unknown. The Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia, and Microvascular Resistance (ORBITA-COSMIC) trial is a randomised, placebo-controlled, double-blind trial investigating the efficacy of the CSR. Patients with (i) established epicardial coronary artery disease, (ii) angina on maximally tolerated antianginal medication, (iii) evidence of myocardial ischaemia and (iv) no further options for percutaneous coronary intervention or coronary artery bypass grafting will be enrolled. Upon enrolment, angina and quality-of-life questionnaires, treadmill exercise testing and quantitative stress perfusion cardiac magnetic resonance (CMR) imaging will be performed. Participants will record their symptoms daily on a smartphone application throughout the trial. After a 2-week symptom assessment phase, participants will be randomised in the cardiac catheterisation laboratory to CSR or a placebo procedure. After 6 months of blinded follow-up, all prerandomisation tests will be repeated. A prespecified subgroup will undergo invasive coronary physiology assessment at prerandomisation and follow-up. The primary outcome is stress myocardial blood flow on CMR. Secondary outcomes include angina frequency, quality of life and treadmill exercise time. (ClinicalTrials.gov: NCT04892537).
Databáze:	MEDLINE
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