Trial reportTrials2013
A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial.
Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01205893 (Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina), which is not on this map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina
Who cites it
11 citing papers in PubMed, 0 citations in OpenAlex.
- A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina.Heart (British Cardiac Society) · 2021Trial
- Efficacy of a device to narrow the coronary sinus in refractory angina.The New England journal of medicine · 2015Trial
- Feature tracking and mapping analysis of myocardial response to improved perfusion reserve in patients with refractory angina treated by coronary sinus Reducer implantation: a CMR study.The international journal of cardiovascular imaging · 2021Observational
- The Coronary Sinus Reducer - Clinical Evidence and New Perspectives On An Emerging Tool in the Treatment of Refractory Angina.Heart international · 2020Review
- Refractory Angina: the Current State of Mechanical Therapies.Current cardiology reports · 2019Review
- Successful percutaneous coronary intervention significantly improves coronary sinus blood flow as assessed by transthoracic echocardiography.Journal of echocardiography · 2018Article
- Safety and efficacy of a device to narrow the coronary sinus for the treatment of refractory angina: A single-centre real-world experience.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2016Article
- Coronary Sinus Stent: Could It Help in Refractory Chronic Stable Angina?Current cardiology reports · 2016Review
- Percutaneous Device to Narrow the Coronary Sinus: Shifting Paradigm in the Treatment of Refractory Angina? A Review of the Literature.Frontiers in cardiovascular medicine · 2016Article
- Treatment of refractory angina in patients not suitable for revascularization.Nature reviews. Cardiology · 2014Review
- Recent publications by ochsner authors.Ochsner journal · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 7 institutions in 4 countries.
Funding
Abstract
backgroundA growing population of patients lives with severe coronary artery disease not amenable to coronary revascularization and with refractory angina despite optimal medical therapy. Percutaneous reduction of the coronary sinus is an emerging treatment for myocardial ischemia that increases coronary sinus pressure to promote a transcollateral redistribution of coronary artery in-flow from nonischemic to ischemic subendocardial territories. A first-in-man study has demonstrated that the percutaneous reduction of the coronary sinus can be performed safely in such patients. The COSIRA trial seeks to assess whether a percutaneous reduction of the coronary sinus can improve the symptoms of refractory angina in patients with limited revascularization options. METHODS/
designThe COSIRA trial is a phase II double-blind, sham-controlled, randomized parallel trial comparing the percutaneously implanted coronary sinus Reducer (Neovasc Inc, Richmond, BC, Canada) to a sham implantation in 124 patients enrolled in Canada, Belgium, England, Scotland, Sweden and Denmark. All patients need to have stable Canadian Cardiovascular Society (CCS) class III or IV angina despite optimal medical therapy, with evidence of reversible ischemia related to disease in the left coronary artery, and a left ventricular ejection fraction >25%. Participants experiencing an improvement in their angina ≥2 CCS classes six months after the randomization will meet the primary efficacy endpoint. The secondary objective of this trial is to test whether coronary sinus Reducer implantation will improve left ventricular ischemia, as measured by the improvement in dobutamine echocardiogram wall motion score index and in time to 1 mm ST-segment depression from baseline to six-month post-implantation. DISCUSSION: Based on previous observations, the COSIRA is expected to provide a significant positive result or an informative null result upon which rational development decisions can be based. Patient safety is a central concern and extensive monitoring should allow an appropriate investigation of the safety related to the coronary sinus Reducer.
trial registrationClinicalTrials.gov identifier - NCT01205893.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.