A novel endothelial damage inhibitor for the treatment of vascular conduits in coronary artery bypass grafting: protocol and rationale for the European, multicentre, prospective, observational DuraGraft registry
| العنوان: | A novel endothelial damage inhibitor for the treatment of vascular conduits in coronary artery bypass grafting: protocol and rationale for the European, multicentre, prospective, observational DuraGraft registry |
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| المؤلفون: | Andreas Böning, Jose Aramendi, Maximilian Y. Emmert, Louis P. Perrault, Martin Misfeld, Yeong-Hoon Choi, Sigrid Sandner, Vilas Satishchandran, Sacha P. Salzberg, Etem Caliskan, Geeta Iyer |
| المساهمون: | University of Zurich, Emmert, Maximilian Y |
| المصدر: | Journal of Cardiothoracic Surgery Journal of Cardiothoracic Surgery, Vol 14, Iss 1, Pp 1-7 (2019) |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Male, Myocardial Infarction, Coronary artery bypass grafting, Coronary Artery Disease, 030204 cardiovascular system & hematology, Study Protocol, 0302 clinical medicine, Vein graft failure, Myocardial infarction, Longitudinal Studies, Prospective Studies, Registries, Coronary Artery Bypass, Stroke, Patency, 11359 Institute for Regenerative Medicine (IREM), General Medicine, Middle Aged, 2746 Surgery, Cardiac surgery, Treatment Outcome, Cardiothoracic surgery, Radial Artery, Saphenous vein graft, Female, Cardiology and Cardiovascular Medicine, Pulmonary and Respiratory Medicine, Reoperation, medicine.medical_specialty, Organ Preservation Solutions, lcsh:Surgery, 610 Medicine & health, 2705 Cardiology and Cardiovascular Medicine, lcsh:RD78.3-87.3, 03 medical and health sciences, medicine.artery, medicine, Humans, Saphenous Vein, Free Arterial Graft, Radial artery, Mammary Arteries, Mortality, Vascular Patency, Aged, Endothelial damage inhibitor, business.industry, Endoscopy, lcsh:RD1-811, medicine.disease, 030228 respiratory system, 2740 Pulmonary and Respiratory Medicine, lcsh:Anesthesiology, Emergency medicine, Quality of Life, Surgery, Observational study, Endothelium, Vascular, business, Mace |
| الوصف: | Background Vein graft disease (VGD) impairs graft patency rates and long-term outcomes after coronary artery bypass grafting (CABG). DuraGraft is a novel endothelial-damage inhibitor developed to efficiently protect the structural and functional integrity of the vascular endothelium. The DuraGraft registry will evaluate the long-term clinical outcomes of DuraGraft in patients undergoing CABG procedures. Methods This ongoing multicentre, prospective observational registry will enrol 3000 patients undergoing an isolated CABG procedure or a combined procedure (ie, CABG plus valve surgery or other surgery) with at least one saphenous vein grafts or one free arterial graft (ie, radial artery or mammary artery). If a patient is enrolled, all free grafts (SVG and arterial will be treated with DuraGraft. Data on baseline, clinical, and angiographic characteristics as well as procedural and clinical events will be collected. The primary outcome measure is the occurrence of a major adverse cardiac event (MACE; defined as death, non-fatal myocardial-infarction, or need for repeat-revascularisation). Secondary outcome measures are the occurrence of major adverse cardiac and cerebrovascular events (MACCE; defined as death, non-fatal myocardial-infarction, repeat-revascularisation, or stroke), patient-reported quality of life, and health-economic data. Patient assessments will be performed during hospitalisation, at 1-month, 1-year, and annually thereafter to 5 years post-CABG. Events will be adjudicated by an independent clinical events committee. This European, multi-institutional registry will provide detailed insights into clinical outcome associated with DuraGraft. Discussion This European, multi-institutional registry will provide detailed insights into clinical outcome associated with the use of DuraGraft. Beyond that, and given the comprehensive data sets comprising of patient, procedural, and graft parameters that are being collected, the registry will enable for multiple subgroup analyses targeting focus groups or specific clinical questions. These may include analysis of subpopulations such as patients with diabetes or multimorbid high-risk patients (patient level), evaluation of relevance of harvesting technique including endoscopic versus open conduit harvesting (procedural level), or particular graft-specific aspects (conduit level). Trial registration ClinicalTrials.gov NCT02922088. Registered October 3, 2016. Ethics and dissemination The regional ethics committees have approved the registry. Results will be submitted for publication. |
| وصف الملف: | Caliskan2019_Article_ANovelEndothelialDamageInhibit.pdf - application/pdf |
| تدمد: | 1749-8090 0292-2088 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9193d5e3a441cd89297893898a0c449aTest https://pubmed.ncbi.nlm.nih.gov/31615560Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....9193d5e3a441cd89297893898a0c449a |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17498090 02922088 |
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