Aortic No-Touch vs Partial Aortic Clamping in Off-Pump CABG

Официальное название

Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting

Обзор

To explore surgical strategies that reduce perioperative neurologic complications in cardiovascular surgery, with the aim of improving perioperative outcomes and quality of life while reducing the socioeconomic burden. Specifically: This multicenter, randomized controlled clinical trial will evaluate the benefits of a novel aortic no-touch technique in reducing perioperative silent brain infarction(SBI) among patients undergoing surgical treatment for coronary artery disease. The findings are expected to provide a safe and effective myocardial revascularization strategy for individuals at high risk of cerebral ischemia.

Вмешательства

• Процедура Aortic no-touch coronary artery bypass grafting (RIMA-SVG)
  Ascending aortic no-touch CABG with saphenous vein graft (SVG) anastomosed to the right internal mammary artery (RIMA)
• Процедура Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG)
  Off-pump CABG with proximal saphenous vein graft (SVG) anastomoses constructed on the ascending aorta using a partial-occlusion (side-biting) clamp.

Первичные конечные точки

• Saphenous vein graft (SVG) occlusion rate [Срок оценки: 1 year after surgery]
• New-onset clinical stroke and silent brain infarction (SBI) [Срок оценки: 7 ± 3 days after surgery]

Вторичные конечные точки (12)

• Incidence of postoperative delirium [Срок оценки: within 5 postoperative days]
• Incidence of perioperative neurocognitive disorder (PND) [Срок оценки: within 7 days after surgery]
• Perioperative major adverse cardiovascular and cerebrovascular events (MACCE) [Срок оценки: within 30 postoperative days]
• MACCE within 3 months after surgery [Срок оценки: Up to 3 months after surgery (3-month follow-up)]
• Clinical stroke within 3 months after surgery [Срок оценки: Up to 3 months after surgery (3-month follow-up)]
• Sternal complications within 3 months after surgery [Срок оценки: Up to 3 months after surgery (3-month follow-up)]
• Cognitive dysfunction at 3 months after surgery [Срок оценки: 3 months after surgery]
• Angina within 12 months after surgery [Срок оценки: 12 months after surgery]
• Cognitive dysfunction at 12 months after surgery [Срок оценки: 12 months after surgery]
• Sternal complications within 12 months after surgery [Срок оценки: Up to 12 months after surgery (12-month follow-up)]
• Clinical stroke within 12 months after surgery [Срок оценки: Up to 12 months after surgery (12-month follow-up)]
• MACCE within 12 months after surgery [Срок оценки: Up to 12 months after surgery (12-month follow-up)]

Критерии участия

Критерии включения

• Adult patients (>18 years old) with multivessel coronary artery disease who are scheduled to undergo isolated off-pump coronary artery bypass grafting and who provide informed consent to participate in this study.

Критерии исключения

• Indications for cardiopulmonary bypass surgery (or no contraindications to on-pump surgery);
• Great saphenous vein is unsuitable for use as a graft conduit;
• Subclavian artery stenosis or occlusion, or any contraindication to the use of the internal mammary artery as a graft conduit;
• History of previous cardiac surgery;
• Emergency surgery;
• Inability to apply an aortic clamp due to severe ascending aortic calcification;
• Expected inability to tolerate MRI or contraindications to MRI (e.g., known intolerance to MRI, an implanted permanent pacemaker, or an anticipated need for permanent pacemaker implantation);
• Inability to complete neurocognitive assessment due to language barriers or visual/hearing impairment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 4 центра

• Fuwai Hospital Chinese Academy of Medical Sciences — Пекин
• Peking University First Hospita — Пекин
• Qingdao Cardiovascular Hospital — Qingdao
• Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen — Шэньчжэнь

Публикации

• Zhao DF, Edelman JJ, Seco M, Bannon PG, Wilson MK, Byrom MJ, Thourani V, Lamy A, Taggart DP, Puskas JD, Vallely MP. Coronary Artery Bypass Grafting With and Without Manipulation of the Ascending Aorta: A Network Meta-Analysis. J Am Coll Cardiol. 2017 Feb 28;69(8):924-936. doi: 10.1016/j.jacc.2016.11.071. PMID 28231944
• Tachibana H, Hiraoka A, Saito K, Naito Y, Chikazawa G, Tamura K, Totsugawa T, Yoshitaka H, Sakaguchi T. Incidence and impact of silent brain lesions after coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2021 Feb;161(2):636-644. doi: 10.1016/j.jtcvs.2019.09.162. Epub 2019 Oct 16. PMID 31735394

Идентификаторы

NCT: NCT07302659 · 2023ZD0504701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗