Optical Coherence Tomography of the Saphenous Vein Graft (OCTOCAB)
Intraoperative Optical Coherence Tomography of the Saphenous Vein Conduit in Patients Undergoing Coronary Artery Bypass Surgery
研究概览
详细说明
Within the first year of coronary artery bypass grafting (CABG) surgery, the saphenous vein grafts have a failure rate of 10 to 25%. Visual inspection of the vein graft conduit is the current standard in determining the quality of the vein segment. However, there may be intraluminal abnormalities that are undetectable via a visual inspection. OCT examination, using the ILUMIEN OPTIS NEXT OCT Imaging system, of endoscopically harvested saphenous vein conduits will indicate such pathology and enable the surgeon to assess the quality of the harvested vein at the intravascular level.
This study is designed to demonstrate the superiority of OCT-guided saphenous vein CABG in improving the rates of early VGF and the overall outcome of CABG.
The study will follow two randomization arms: OCT-guided saphenous vein CABG (interventional arm) vs. visual inspection-guided saphenous vein CABG (standard of care arm). The analysis of subjects will be with respect to their analyzed group.
Following enrollment, participants will be followed for up to 10 years. The primary endpoint is per graft incidence of vein graft failure. The assessment of the vein graft will be conducted via coronary CT angiogram (CCTA) at 12 months. In the case where the participant has unplanned angiogram due to clinical reasons, prior to the 12 months, the condition of the graft will be determined via the angiogram. Unless all target grafts have reached the endpoint prior to the 12 month time point, a CCTA will be required.
To achieve the power level of 85% at the significance level of 0.025, 760 patients is the anticipated sample size. Analysis will be conducted at the graft level with a Linear Mixed model to account for any potential patient effects.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Ziad A. Ali, MD,DPhil
- 电话号码:516-622-4552
- 邮箱:ziadali.mail@gmail.com
研究联系人备份
- 姓名:Elizabeth S. Haag, RN
- 电话号码:516-622-4552
- 邮箱:Elizabeth.Haag@chsli.org
学习地点
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New York
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Roslyn、New York、美国、11576
- 招聘中
- St Francis Hospital
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接触:
- Elizabeth S. Haag, RN
- 电话号码:516-622-4512
- 邮箱:Elizabeth.Haag@chsli.org
-
接触:
- Ziad A. Ali, MD, DPhil
- 电话号码:516-622-4552
- 邮箱:ziadali.mail@gmail.com
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subject must be at least 18 years of age.
- Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective CABG.
- Subject must have undergone coronary angiography identifying at least one lesion that is clinically appropriate and suitable for saphenous vein bypass grafting.
- Subject must provide written Informed Consent prior to any study related procedure.
Exclusion Criteria:
- STEMI ≤24 hours from the onset of ischemic symptoms
- Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis.
- Hypotension, shock or need for mechanical support or intravenous vasopressors at the time that the patient would be undergoing the index procedure.
- CHF (Killip class >2 or NYHA class >3)
- LVEF <30% by the most recent imaging test within 6 months prior to procedure. If no LVEF test result within 6 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method.
- Unstable ventricular arrhythmias
- Concomitant multi-valve surgery or major aortic root surgery.
- Planned non-cardiac surgery within 24 months after the index procedure
- Prior CABG
- Any planned PCI within any target vessel(s) within 24 months.
- Subject has known hypersensitivity or contraindication to any of the study drugs (including aspirin, all P2Y12 inhibitors).
- Subject has received a heart transplant.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
- Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
- Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
- Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- Subject has a history of bleeding diathesis or coagulopathy.
- Subject has life expectancy <2 years for any non-cardiac cause.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Conduit exclusion criteria
1. Severe conduit tortuosity of venous conduit (e.g., with varicosities) such that it is unlikely that the OCT catheter can be delivered without vascular damage.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:OCT-guided saphenous vein graft coronary artery bypass graft surgery
Optical Coherence Tomography (OCT) provides high quality intravascular images by using infrared light.
OCT will assess the harvested saphenous vein conduit in Coronary Bypass Graft Surgery (CABG).
Abnormalities found in the harvested conduits via OCT, at the discretion of the surgeon, will not be utilized for CABG.
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OCT examination of harvested saphenous vein conduits will indicate pathology.
Under the surgeon's discretion the conduit segments with pathology will not be grafted.
其他名称:
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无干预:Visual inspection-guided saphenous vein graft coronary artery graft surgery
Harvested saphenous vein conduits will be assessed visually and will undergo a blinded OCT.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Vein graft failure (VGF)
大体时间:12 months
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Per graft incidence of VGF defined as greater than or equal to 70% in the body of the graft on coronary CT angiography (CCTA)
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
全因死亡率
大体时间:12个月
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12个月
|
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Target graft failure (TGF)
大体时间:12 months
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Composite time-to-first event rate of cardiac death, target graft myocardial infarction (TG-MI), or ischemia-driven target graft revascularization (ID-TGR)
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12 months
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Per graft incidence of ischemic vein graft failure
大体时间:12 months
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Greater than or equal to 70% stenosis
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12 months
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Per graft incidence anatomic vein graft failure
大体时间:12 months
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Greater than or equal to 50% stenosis
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12 months
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Per patient incidence of vein graft patency
大体时间:12 months
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Vein graft having less than 50% stenosis
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12 months
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Per patient incidence of ischemic vein graft failure
大体时间:12 months
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Greater than or equal to 70% stenosis
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12 months
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Per patient incidence of anatomic vein graft failure
大体时间:12 months
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Greater than or equal to 50% stenosis
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12 months
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Mean vein graft diameter stenosis
大体时间:12 months
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12 months
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Mean vein graft area stenosis
大体时间:12 months
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12 months
|
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Cardiac and non-cardiac mortality
大体时间:12 months
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12 months
|
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All Myocardial Infarction (MI)
大体时间:12 months
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12 months
|
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Target graft myocardial infarction (TG-MI) and Non-Target graft myocardial infarction (non-TG-MI)
大体时间:12 months
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12 months
|
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All revascularization
大体时间:12 months
|
12 months
|
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Ischemia driven (ID)-revascularization and Non-ischemia driven (ID)-revascularization
大体时间:12 months
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12 months
|
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Ischemia driven-target graft failure (ID-TGR)
大体时间:12 months
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12 months
|
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Ischemia driven (ID)-revascularization of target native coronary artery subtended by the graft
大体时间:12 months
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12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Intimal injury
大体时间:12 months
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Major - Disruption of intima with arc ≥ 60˚ AND length: ≥ 2 mm Minor - Disruption of intima with arc <60˚ AND length: <2 mm
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12 months
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Intraluminal mass
大体时间:12 months
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Major - Mass extending ≥ 5 cm and ≥ 2 mm in diameter Minor - Mass extending < 5 cm and < 2 mm in diameter
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12 months
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Intramural hematoma
大体时间:12 months
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Major - ≥ 60˚ arc and length ≥ 5mm Minor - < 60˚ arc and length < 5mm
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12 months
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Valvular sclerosis
大体时间:12 months
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Major - > 0.25mm thickness Minor - ≤ 0.25mm thickness with redundant valve tissue
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12 months
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Immunohistochemistry
大体时间:12 months
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Relationship between the OCT-identified abnormalities with immunohistochemistry in the surplus and OCT-guided excluded segments of vein grafts for histological validation of OCT-identified abnormal findings.
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12 months
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Transit-Time Flow Meter (TTFM)
大体时间:12 months
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All grafts will be assessed with TTFM to assess anastomosis.
Data will be reviewed to determine whether TTFM abnormalities correlated to OCT findings.
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12 months
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Relationship between OCT parameters and endpoint rates
大体时间:12 months
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12 months
|
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Relationship between OCT parameters at baseline in the standard of care arm with OCT findings in vivo during follow-up
大体时间:12 months
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12 months
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合作者和调查者
调查人员
- 首席研究员:Ziad A. Ali, MD,DPhil、Saint Francis Memorial Hospital
- 首席研究员:Edward F. Lundy, MD, PhD、Saint Francis Memorial Hospital
出版物和有用的链接
一般刊物
- Caliskan E, de Souza DR, Boning A, Liakopoulos OJ, Choi YH, Pepper J, Gibson CM, Perrault LP, Wolf RK, Kim KB, Emmert MY. Saphenous vein grafts in contemporary coronary artery bypass graft surgery. Nat Rev Cardiol. 2020 Mar;17(3):155-169. doi: 10.1038/s41569-019-0249-3. Epub 2019 Aug 27.
- Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.
- Antonopoulos AS, Odutayo A, Oikonomou EK, Trivella M, Petrou M, Collins GS, Antoniades C; SAFINOUS-CABG (Saphenous Vein Graft Failure-An Outcomes Study in Coronary Artery Bypass Grafting) group. Development of a risk score for early saphenous vein graft failure: An individual patient data meta-analysis. J Thorac Cardiovasc Surg. 2020 Jul;160(1):116-127.e4. doi: 10.1016/j.jtcvs.2019.07.086. Epub 2019 Aug 26.
- Gaudino M, Di Franco A, Bhatt DL, Alexander JH, Abbate A, Azzalini L, Sandner S, Sharma G, Rao SV, Crea F, Fremes SE, Bangalore S. The association between coronary graft patency and clinical status in patients with coronary artery disease. Eur Heart J. 2021 Apr 7;42(14):1433-1441. doi: 10.1093/eurheartj/ehab096.
- Tan ES, van der Meer J, Jan de Kam P, Dunselman PH, Mulder BJ, Ascoop CA, Pfisterer M, Lie KI. Worse clinical outcome but similar graft patency in women versus men one year after coronary artery bypass graft surgery owing to an excess of exposed risk factors in women. CABADAS. Research Group of the Interuniversity Cardiology Institute of The Netherlands. Coronary Artery Bypass graft occlusion by Aspirin, Dipyridamole and Acenocoumarol/phenoprocoumon Study. J Am Coll Cardiol. 1999 Nov 15;34(6):1760-8. doi: 10.1016/s0735-1097(99)00404-0.
- Goldman S, Copeland J, Moritz T, Henderson W, Zadina K, Ovitt T, Doherty J, Read R, Chesler E, Sako Y, et al. Saphenous vein graft patency 1 year after coronary artery bypass surgery and effects of antiplatelet therapy. Results of a Veterans Administration Cooperative Study. Circulation. 1989 Nov;80(5):1190-7. doi: 10.1161/01.cir.80.5.1190.
- Mehta RH, Ferguson TB, Lopes RD, Hafley GE, Mack MJ, Kouchoukos NT, Gibson CM, Harrington RA, Califf RM, Peterson ED, Alexander JH; Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Investigators. Saphenous vein grafts with multiple versus single distal targets in patients undergoing coronary artery bypass surgery: one-year graft failure and five-year outcomes from the Project of Ex-Vivo Vein Graft Engineering via Transfection (PREVENT) IV trial. Circulation. 2011 Jul 19;124(3):280-8. doi: 10.1161/CIRCULATIONAHA.110.991299. Epub 2011 Jun 27.
- Hattler B, Messenger JC, Shroyer AL, Collins JF, Haugen SJ, Garcia JA, Baltz JH, Cleveland JC Jr, Novitzky D, Grover FL; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. Off-Pump coronary artery bypass surgery is associated with worse arterial and saphenous vein graft patency and less effective revascularization: Results from the Veterans Affairs Randomized On/Off Bypass (ROOBY) trial. Circulation. 2012 Jun 12;125(23):2827-35. doi: 10.1161/CIRCULATIONAHA.111.069260. Epub 2012 May 16.
- Raza S, Blackstone EH, Houghtaling PL, Rajeswaran J, Riaz H, Bakaeen FG, Lincoff AM, Sabik JF 3rd. Influence of Diabetes on Long-Term Coronary Artery Bypass Graft Patency. J Am Coll Cardiol. 2017 Aug 1;70(5):515-524. doi: 10.1016/j.jacc.2017.05.061.
- Sabik JF 3rd, Lytle BW, Blackstone EH, Houghtaling PL, Cosgrove DM. Comparison of saphenous vein and internal thoracic artery graft patency by coronary system. Ann Thorac Surg. 2005 Feb;79(2):544-51; discussion 544-51. doi: 10.1016/j.athoracsur.2004.07.047.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 21-10
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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