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临床试验/NCT06078410
NCT06078410招募中不适用

A Prospective Cohort Study of Neurologic Evaluation in Patients Recevied Transapical Beating-heart Septal Myectomy or General Cardiac Surgery

Xiang Wei1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
The incidence of diffusion-weighted MRI lesions

研究概览

简要总结

The goal of this prospective cohort study is to evaluate the neurologic changes in patients that received transapical beating-heart septal myectomy. The main questions are: whether this novel operation way would cause neurologic impairment; whether this novel operation way have similar neurologic lesions, compared to other cardiac surgery ways. Participants will undergo detailed neurologic and cognitive assessment at baseline, after procedure, and at 30 days. Researchers will compare the clinically relevant manifestations and brain lesions measured by cognitive evaluation forms of the nervous system (i.e. Montreal cognitive assessment) and diffusion-weighted magnetic resonance imaging (DW-MRI) to assess the safety of transapical beating-heart septal myectomy on nervous system.

详细描述

Nervous system complication is one of the common complications caused by cardiac surgery, including ischemic stroke, encephalopathy, neurocognitive dysfunction, which can increase the mortality of patients, hospitalization cost and lead to long-term quality of life impairment. At present, embolism is considered to be the main mechanism of postoperative nervous system complication. Imaging studies have confirmed that 30% to 50% of perioperative strokes are caused by brain embolism larger than 200 μm. For example, a study using diffusion-weighted magnetic resonance imaging (DW-MRI) found that 66% of patients who received aortic valve replacement had a new cerebral infarction with a brain injury volume of about 126 mm3. Recently, our team have invented a novel surgical method called transapical beating-heart septal myectomy (TA-BSM) to cure hypertrophic obstructive cardiomyopathy (HOCM). To date, this novel therapy displayed ideal effectiveness on these patients, however, whether this novel operation way would cause neurologic impairment is unclear. In this study, researchers will compare TA-BSM with cardiac surgery involving left heart operation, and analyze the clinically relevant manifestations and brain lesions measured by cognitive evaluation forms of the nervous system (i.e., Montreal cognitive assessment) and diffusion-weighted magnetic resonance imaging (DW-MRI) in these patients received above therapies. This study is to assess the safety of TA-BSM on nervous system and contributes the further improvement of this novel cardiac surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • meets indications for transapical beating-heart septal myectomy procedure or these cardiac surgery involving left heart operation, such as hypertrophic obstructive cardiomyopathy, mitral valve prolapse, and ventricular septal defect; willing to comply with protocol-specified follow-up evaluations.

排除标准

  • severe brain infarction, such stroke and cerebral hemorrhage recently; the implantation of metal materials, including Pacemaker; not able to undergo MRI examination; peptic ulcer or recent gastrointestinal bleeding (<6 months); the history of myocardial infarction; cognitive impairment in the past; not able to finish nervous system evaluation scale.

结局指标

主要结局

The incidence of diffusion-weighted MRI lesions

时间窗: 3 months

the number (n) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months

The volume of new brain lesions measured by diffusion-weighted MRI

时间窗: 3 months

the volume (mL) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months

次要结局

  • national Institute of Health stroke scale(7 days and 3 months)
  • modified rankin scale(7 days and 3 months)
  • neurologic injury(7 days and 3 months)
  • all-cause and cardiovascular mortality(7 days and 3 months)
  • montreal cognitive assessment(7 days and 3 months)
  • symbol digit modalities test(7 days and 3 months)
  • trail-making-test(7 days and 3 months)

研究者

发起方
Xiang Wei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiang Wei

Professor and Director

Tongji Hospital

研究点 (1)

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