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
Background A 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 c...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BioMed Central Ltd.
2013
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| Online Access: | http://hdl.handle.net/1721.1/77976 https://orcid.org/0000-0002-7832-7156 |
| _version_ | 1826204207949021184 |
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| author | Jolicœur, E. Marc Banai, Shmuel Henry, Timothy D. Schwartz, Marc Doucet, Serge White, Christopher J. Edelman, Elazer R. Verheye, Stefan |
| author2 | Harvard University--MIT Division of Health Sciences and Technology |
| author_facet | Harvard University--MIT Division of Health Sciences and Technology Jolicœur, E. Marc Banai, Shmuel Henry, Timothy D. Schwartz, Marc Doucet, Serge White, Christopher J. Edelman, Elazer R. Verheye, Stefan |
| author_sort | Jolicœur, E. Marc |
| collection | MIT |
| description | Background
A 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/Design
The 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. |
| first_indexed | 2024-09-23T12:50:35Z |
| format | Article |
| id | mit-1721.1/77976 |
| institution | Massachusetts Institute of Technology |
| language | English |
| last_indexed | 2024-09-23T12:50:35Z |
| publishDate | 2013 |
| publisher | BioMed Central Ltd. |
| record_format | dspace |
| spelling | mit-1721.1/779762022-09-28T10:21:55Z 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 Jolicœur, E. Marc Banai, Shmuel Henry, Timothy D. Schwartz, Marc Doucet, Serge White, Christopher J. Edelman, Elazer R. Verheye, Stefan Harvard University--MIT Division of Health Sciences and Technology Edelman, Elazer R. Background A 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/Design The 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. Neovasc Inc. 2013-03-21T20:15:05Z 2013-03-21T20:15:05Z 2013-02 2012-08 2013-03-17T08:08:45Z Article http://purl.org/eprint/type/JournalArticle 1745-6215 http://hdl.handle.net/1721.1/77976 Jolicœur, E Marc et al. “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.” Trials 14.1 (2013): 46. CrossRef. Web. https://orcid.org/0000-0002-7832-7156 en http://dx.doi.org/10.1186/1745-6215-14-46 Trials Creative Commons Attribution http://creativecommons.org/licenses/by/2.0 E Marc Jolicœur et al.; licensee BioMed Central Ltd. application/pdf BioMed Central Ltd. BioMed Central Ltd |
| spellingShingle | Jolicœur, E. Marc Banai, Shmuel Henry, Timothy D. Schwartz, Marc Doucet, Serge White, Christopher J. Edelman, Elazer R. Verheye, Stefan 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://hdl.handle.net/1721.1/77976 https://orcid.org/0000-0002-7832-7156 |
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