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| Name | Class |
|---|---|
| Beijing Municipal Administration of Hospitals | OTHER_GOV |
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This study aims to investigate the clinical effect of the new saphenous vein harvesting technique "No-touch" in off-pump coronary artery bypass grafting(OPCABG), comparing to the conventional technique. Adopting CTA to evaluate the 3 months patency of the graft, we will compare veins harvested using No-touch technique to saphenous veins using conventional open technique.
Coronary artery disease(CAD) is a widespread health issue around the world. It is proven that atherosclerosis is a inflammatory disease, and endothelial dysfunction is one of the key factors that initiates the inflammatory response. Accumulating studies indicate that endothelial homeostasis plays a primordial role in the development of atherosclerosis.
Coronary artery bypass grafting(CABG) is the standard treatment of three-vessel or left main coronary artery disease, and its long-term benefits is apparent. Saphenous vein is the most common graft in CABG, however, the long-term patency is only about 50% in one year, as a result, it is urgent to discover a solution to improve the long term potency of vein grafts.
Conventional harvesting technique dissects the perivascular tissue and inject saline to check leakage, which causes damages to the endothelium of the vein, initiating inflammatory response. No-touch technique is a atraumatic, non-distended harvesting technique. According to the criteria, we will randomize the patients into two groups, the conventional and No-touch group, the vein will be used in sequential anastomosis, by comparing the 3 months patency rate assessed by CTA, we aim to compare the clinical outcomes of the two different vein harvesting techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | The perivascular tissue is stripped off when harvesting the vein, and saline will be used to distend the vein to check for leakage. |
|
| No-touch | Experimental | The vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional vein harvesting technique | Procedure | Long incision will be used to expose the vein, the perivascular tissue will be dissected carefully by scissors, to check for leakage, the vein will be distended by injecting saline. |
| Measure | Description | Time Frame |
|---|---|---|
| short-term patency rate of vein grafts | the patency of vein grafts will be assessed by CTA, the doctors of CT department will be masked, at least 2 doctors will provide their conclusions.when the results is controversial, the third doctor will be asked to review the image and provide another conclusion, the patency will be assessed according all results. | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| long-term patency rate of vein grafts | the patency will be assessed by CTA the same as short-term patency | 12 months after surgery |
| major adverse cardiac and cerebrovascular events(MACCE) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ju-bing Zheng, M.D. | Contact | 86-13683113119 | zhengjubing@hotmail.com | |
| Kui Zhang, M.D. | Contact | 86-15001178663 |
| Name | Affiliation | Role |
|---|---|---|
| Ju-bing Zheng, M.D. | Beijing Anzhen Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital medical university | Recruiting | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39076438 | Derived | Peng Z, Zhao R, Yang Y, Hua K, Yang X. Predictive Value of the CT-Based Visceral Adiposity Tissue Index and Triglyceride-Glucose Index on New-Onset Atrial Fibrillation after Off-Pump Coronary Artery Bypass Graft: Analyses from a Longitudinal Study. Rev Cardiovasc Med. 2023 Nov 30;24(11):338. doi: 10.31083/j.rcm2411338. eCollection 2023 Nov. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| no-touch vein harvesting technique | Procedure | The vein will be harvested by low-frequency electrotome, about 5mm surrounding tissue will be preserved with the vein, distention should be avoided, the vein will not be cut off until being anastomosed. |
|
all-cause death, myocardial infarction, stroke,repeat revascularizaiton
| 3 months and 12 months after surgery |
| CCS grade | the grade of angina wii be assessed according to Canadian Cardiovascular Society standard | 3 months and 12 months after surgery |
| the healing of the lower leg incision | the healing of the incision will be divided into primary healing, e.g. less tissue defects, neat wound edges, no infection, adhesion or suture to create a tight wound; delayed healing, which means the wound does not closed within 1 month; infection, the wound does not close after 3 months, or necrotic tissues are seen in the incision. | 3 months and 12 months after surgery |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |