ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Neuropsychological assessment 1
研究概览
简要总结
In a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT), designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3 months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the filter groups compared to the controls. Secondary endpoint is the number of acute ischemic lesions after CABG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age > 18
- •Elective aortic valve replacement
- •Informed consent
- •German language
排除标准
- •Neurological and psychiatric diseases that would conflict with neuropsychological testing (e.g. stroke, TBI, schizophrenia, etc.); further major surgeries on CPB planned for within 3 months after valve replacement
- •Contraindication against MRI assessment
结局指标
主要结局
Neuropsychological assessment 1
时间窗: 3 weeks to 1 day before intervention
Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures
Neuropsychological assessment 2
时间窗: 3 months (+/- 1 week) post intervention
Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures
次要结局
- MRI lesions detected after surgery(2-6 days postoperative)