Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Subclinical stroke rate
研究概览
简要总结
Rationale When determining the strategy for aortic valve replacement, echocardiography is still considered the golden standard (1). While pre-procedural MSCT is standard of care in TAVR patients, this is not yet part of routine clinical practice in SAVR patients. The researchers hypothesise that when atherosclerosis of the ascending aorta is identified preoperatively on contrast-enhanced multi-slice computed tomography (MSCT), the subclinical perioperative stroke rate (as detected on diffusion-weighted magnetic resonance imaging (DW-MRI)) can be reduced by modification of the operative strategy if necessary.
详细描述
When determining the strategy for aortic valve replacement, echocardiography is still considered the golden standard (1). While pre-procedural MSCT is standard of care in TAVR patients, this is not yet part of routine clinical practice in SAVR patients. The investigators hypothesise that when atherosclerosis of the ascending aorta is identified preoperatively on contrast-enhanced multi-slice computed tomography (MSCT), the subclinical perioperative stroke rate (as detected on diffusion-weighted magnetic resonance imaging (DW-MRI)) can be reduced by modification of the operative strategy if necessary.
The primary objective is to assess whether the use of pre-operative MSCT will reduce subclinical stroke rates (i.e., ischemic brain lesions) as identified with the use of DW-MRI after SAVR with or without concomitant CABG surgery.
The secondary objective is to assess whether the use of pre-operative MSCT will improve neurological assessment score, reduce clinical stroke, mortality, change in intervention strategy (pre- or intra-operatively), cannulation strategy and clamping strategy as well as reduce procedural times and improve quality of life (with the application of EQ-5D and KCCQ questionnaires).
This is a prospective, multicenter, parallel, open-label randomized controlled trial (RCT) with a 1:1 randomization including patients aged 18 years and older accepted for SAVR with or without concomitant CABG by the Heart Team at the St. Antonius Hospital Nieuwegein. All patients enrolled in the study will be randomized to additional pre-operative MSCT or no additional pre-operative MSCT. Postoperatively, a DW-MRI will be made in all patients. The trial will end after 30-day follow-up of all enrolled patients.
The main primary endpoint is the incidence of subclinical stroke rate (i.e., presence of new ischemic brain lesions) as identified with the use of DW-MRI made within one week postoperatively or before discharge. Secondary endpoints include the National Institutes of Health Stroke Scale (NIHSS) score within one week postoperatively (targeted at day two postoperatively), clinical ischemic stroke (conform VARC-3),transient ischemic attack diagnosed by a neurologist within one week postoperatively, defined by transient focal neurological signs or symptoms lasting < 24 h presumed to be due to focal brain, spinal cord or retinal ischemia, but without evidence of acute infarction by neuroimaging or pathology, or with no imaging performed (conform VARC-3), mortality at discharge (normally at three to five days postoperatively) or within one week postoperatively (if discharge is > 1 week postoperatively) and at three months postoperatively, the change in intervention strategy, the change in cannulation strategy, the change in clamping strategy, procedural times and the quality of life at three months postoperatively (assessed by EQ-5D and KCCQ)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary symptomatic severe aortic valve stenosis (defined as an aortic valve area of <1.0cm2 and either a mean valve gradient of at least 40mmHg or a peak velocity of at least 4.0 m/s)
- •Accepted for SAVR (either planned to be done by a limited access approach (partial J-shaped sternotomy or right anterior thoracotomy or conventional median sternotomy approach at the preference of the patient and/or the discretion of the surgeon) with or without concomitant CABG by the Heart Team
- •Informed consent
排除标准
- •Previous aortic valve replacement
- •Emergency procedure
- •Pregnant women
- •Renal failure (eGFR <30 ml/min.)
- •Known contrast allergy
- •Patient unwilling to be informed about unrequested findings on the CT scan or DW-MRI scan
- •Contra-indication for MRI (e.g. permanent pacemaker or ICD that can not be inactivated per order of the pacemaker or ICD technician, morphine or insulin pump, neurostimulator). All patients will fill out a MRI checklist to additionally check for (new) safety contra-indications for MRI.
- •Patient who did not agree to the informed consent and/or refused to participate
- •Patient unable to understand the informed consent/study
结局指标
主要结局
Subclinical stroke rate
时间窗: Within 90 days post procedure
Subclinical stroke rate (i.e., presence of new ischemic brain lesions) as identified with the use of DW-MRI made within one week postoperatively or before discharge (in case of prolonged ICU stay).
次要结局
- National Institutes of Health Stroke Scale(within one week postoperatively (targeted at day two postoperatively))
- Clinical ischemic stroke (conform VARC-3)(Within one week postoperatively)
- TIA diagnosed by a neurologist(One week postoperatively)
- Change in intervention strategy(After hospital admission but before the end of surgery)
- Change in cannulation strategy(During procedure)
- Change in clamping strategy(During procedure)
- Procedural times(During procedure)
- Quality of life at three months postoperatively (assessed by EQ-5D and KCCQ)(At baseline (prior to procedure) and 90 days post procedure)
研究者
Romy Hegeman
Research Coordinator
St. Antonius Hospital