Recruiting NCT07302659
Aortic No-Touch vs Partial Aortic Clamping in Off-Pump CABG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aortic no-touch coronary artery bypass grafting (RIMA-SVG), Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG).
- Who it may be relevant to
- Registry conditions: Coronary Artery Bypass Graft (CABG). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting
Overview
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.
Interventions
- Procedure 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) - Procedure 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.
Primary outcome measures
- Saphenous vein graft (SVG) occlusion rate [Time frame: 1 year after surgery]
- New-onset clinical stroke and silent brain infarction (SBI) [Time frame: 7 ± 3 days after surgery]
Secondary outcome measures (12)
- Incidence of postoperative delirium [Time frame: within 5 postoperative days]
- Incidence of perioperative neurocognitive disorder (PND) [Time frame: within 7 days after surgery]
- Perioperative major adverse cardiovascular and cerebrovascular events (MACCE) [Time frame: within 30 postoperative days]
- MACCE within 3 months after surgery [Time frame: Up to 3 months after surgery (3-month follow-up)]
- Clinical stroke within 3 months after surgery [Time frame: Up to 3 months after surgery (3-month follow-up)]
- Sternal complications within 3 months after surgery [Time frame: Up to 3 months after surgery (3-month follow-up)]
- Cognitive dysfunction at 3 months after surgery [Time frame: 3 months after surgery]
- Angina within 12 months after surgery [Time frame: 12 months after surgery]
- Cognitive dysfunction at 12 months after surgery [Time frame: 12 months after surgery]
- Sternal complications within 12 months after surgery [Time frame: Up to 12 months after surgery (12-month follow-up)]
- Clinical stroke within 12 months after surgery [Time frame: Up to 12 months after surgery (12-month follow-up)]
- MACCE within 12 months after surgery [Time frame: Up to 12 months after surgery (12-month follow-up)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 4 centers
- Fuwai Hospital Chinese Academy of Medical Sciences — Beijing
- Peking University First Hospita — Beijing
- Qingdao Cardiovascular Hospital — Qingdao
- Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen — Shenzhen
Publications
- 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
Identifiers
NCT: NCT07302659 · 2023ZD0504701