Clinical trial NCT06078410: Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy
Official title: A Prospective Cohort Study of Neurologic Evaluation in Patients Recevied Transapical Beating-heart Septal Myectomy or General Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic Obstructive Cardiomyopathy \(HOCM\)
Neurologic Evaluation
Magnetic Resonance Imaging \(MRI\)
Transapical Beating-Heart Septal Myectomy
Cardiac Surgery Involving Left Heart Operation
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients suffer from hypertrophic obstructive cardiomyopathy or the other cardiovascular disease and have to receive cardiac surgery involving left heart operation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: The incidence of diffusion-weighted MRI lesions
timeFrame: 3 months
measure: The volume of new brain lesions measured by diffusion-weighted MRI
timeFrame: 3 months
Secondary outcomes:
measure: neurologic injury
timeFrame: 7 days and 3 months
measure: all-cause and cardiovascular mortality
timeFrame: 7 days and 3 months
measure: montreal cognitive assessment
timeFrame: 7 days and 3 months
measure: national Institute of Health stroke scale
timeFrame: 7 days and 3 months
measure: modified rankin scale
timeFrame: 7 days and 3 months
measure: symbol digit modalities test
timeFrame: 7 days and 3 months
measure: trail-making-test
timeFrame: 7 days and 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xiang Wei, M.D.
role: STUDY_CHAIR
References:
citation: Fang J, Wang R, Liu H, Su Y, Chen J, Han X, Wei Y, Chen Y, Cheng L, Wei X. Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):303-311. doi: 10.1093/icvts/ivz249.