Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy

Recruiting

• Conditions: Cardiac Surgery Involving Left Heart Operation; Neurologic Evaluation; Hypertrophic Obstructive Cardiomyopathy \(HOCM\); Magnetic Resonance Imaging \(MRI\); Transapical Beating-Heart Septal Myectomy
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT06078410
• Lead Sponsor: Xiang Wei

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.

Study Timeline

• Study First Submitted: 2023-09-27
• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted QC: 2023-10-08
• Last Update Submitted: 2023-10-08
• Study First Posted: 2023-10-11
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TA-BSM	Cardiac surgery	patients received transapical beating-heart septal myectomy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
national Institute of Health stroke scale	7 days and 3 months	national Institute of Health stroke scale evaluating mild cognitive impairment, ranging from 0 to 42, in which higher scores mean a worse outcome.
modified rankin scale	7 days and 3 months	modified rankin scale evaluating mild cognitive impairment, ranging from 0 to 6, in which higher scores mean a worse outcome.
neurologic injury	7 days and 3 months	The number of participants (n) with neurological events and cognitive dysfunction following transapical beating-heart septal myectomy
all-cause and cardiovascular mortality	7 days and 3 months	all-cause and cardiovascular mortality following transapical beating-heart septal myectomy
montreal cognitive assessment	7 days and 3 months	montreal cognitive assessment evaluating mild cognitive impairment, ranging from 0 to 30, in which higher scores mean a better outcome.
symbol digit modalities test	7 days and 3 months	symbol digit modalities test evaluating mild cognitive impairmentt, ranging from 0 to 90, in which higher scores mean a better outcome.
trail-making-test	7 days and 3 months	trail-making-test evaluating mild cognitive impairment, in which the longer time mean a worse outcome.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China