Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion:a Randomized H215O PET/CT Study (VANISH)
Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: a Randomized H215O PET/CT Study
研究概览
详细说明
Objective The objective of the proposed study is to determine the impact of VRT, in comparison with conventional drug-eluting stenting, on endothelium dependent vasodilation and maximal hyperemic myocardial perfusion using H215O PET.
Study design The study is designed as a single center single-blind randomized clinical trial and will be conducted at the VU University Medical Center in Amsterdam.
Summary of the study design It is hypothesized that VRT will result in augmented endothelium dependent coronary vasodilation and maximal myocardial perfusion as compared with conventional stenting of a coronary lesion. Within one year sixty patients (age 18-65) with documented single vessel CAD (type A or B1 lesion) accepted for PCI based on clinical grounds and according to current international guidelines, will be asked to participate in this trial. Patients will be randomized to implantation of a drug-eluted stent (Xience Prime) or BRS (Absorb). The patients will be blinded to the nature of the implanted device. H2 15O PET will be performed one month (reference scan), one year, and three years after the PCI procedure (resolution of BRS is generally complete within a three year period). The PET protocol will consist of three MBF measurements: resting MBF, during endothelial dependent vasodilation provoked by coldpressor-testing (CPT), and during (endothelial dependent and independent) maximal vasodilation by infusion of adenosine intravenously. After three years a control invasive coronary angiogram will document any potential obstructive coronary lesions that may affect the MBF measurements.
Primary study parameters/outcome of the study MBF measurements: resting MBF, during endothelial dependent vasodilation provoked by cold-pressor-testing (CPT), and during (endothelial dependent and independent) maximal vasodilation by infusion of adenosine intravenously
Secondary study parameters/outcome of the study Obstructive coronary lesions on control invasive coronary angiogram that may affect the MBF measurements.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Noord-Holland
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Amsterdam、Noord-Holland、荷兰、1081 HV
- VU University Medical Center
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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:
- Patients with documented obstructive CAD by invasive coronary angiography resulting in myocardial ischemia (either documented by invasive (i.e. fractional flow reserve, FFR) or noninvasive imaging techniques (e.g. exercise ECG, myocardial perfusion imaging, or inducibility of wall motion abnormalities during dobutamine stress).
- Presence of a single, de-novo lesion in a native coronary artery (type A or B1), with a reference vessel diameter of at least 3.0 mm and a diameter stenosis of 50% or more and less than 100%, with a thrombolysis in myocardial infarction (TIMI) flow grade of at least 2. Coronary lesion must be amendable for successful treatment with one of the following BRS device dimensions: length 18 or 28 mm, diameter 3.0 or 3.5 mm.
Exclusion Criteria:
- age of 65 or above
- refusal or inability to provide written informed consent
- other than single CAD
- abnormal echocardiographic findings (i.e. wall motion abnormalities, ventricular hypertrophy, valvular disease etc.)
- complex coronary lesion characteristics (e.g. lesions located in the left main coronary artery, lesions involving a side branch more than 2 mm in diameter, and the presence of thrombus or another clinically significant stenosis in the target vessel)
- poor kidney function defined as an eGFR < 30 ml/min
- astma or chronic obstructive pulmonary disease
- other than sinus rhythm
- pregnancy
- bail out stenting after placement of the study device
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Bioresorbable vascular scaffold
Paritcipants will receive a bioresorbable vascular scaffols (BVS)
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Drug eluting coronary stent, resorbable in 2-3 years
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有源比较器:Xience Prime
Participant will receive a Xience Prime stent
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Drug eluting metallic stent
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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 |
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Evaluation of Myocardial Blood Flow over time
大体时间:Three years
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Endothelial dependent vasomotor function and effect on myocardial perfusion
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Three years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Restenosis
大体时间:Three years
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Obstructive coronary lesions and lumen dimensions on control invasive coronary angiogram that may affect the MBF measurements
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Three years
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合作者和调查者
调查人员
- 首席研究员:Paul Knaapen, MD, PhD、Amsterdam Umc, Location Vumc
研究记录日期
研究主要日期
学习开始
初级完成 (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 (估计)
研究记录更新
最后更新发布 (估计)
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
- VANISH
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Bioresorbable vascular scaffold的临床试验
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Fogarty Clinical Research Inc.Abbott Medical Devices; Helen Kay Foundation; Northern Michigan Hospital Foundation's Louis A....未知
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Universitätsklinikum KölnThe Clinical Trials Centre Cologne未知
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Abbott Medical Devices完全的