Hypertrophic Obstructive Cardiomyopathy \(HOCM\)NCT06078410
Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy
An observational study of Hypertrophic Obstructive Cardiomyopathy \(HOCM\) and Neurologic Evaluation, run by Xiang Wei at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Neurologic Evaluation, Magnetic Resonance Imaging \(MRI\)
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients suffer from hypertrophic obstructive cardiomyopathy or the other cardiovascular disease and have to receive cardiac surgery involving left heart operation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Xiang Wei, M.D., +8613995525956, xiangwei@tjh.tjmu.edu.cn
Jing Fang, M.D., +8613296640596, jingfang@hust.edu.cn
About this study
Official title: A Prospective Cohort Study of Neurologic Evaluation in Patients Recevied Transapical Beating-heart Septal Myectomy or General Cardiac Surgery
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.
Read the 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.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Neurologic Evaluation, Magnetic Resonance Imaging \(MRI\), Transapical Beating-Heart Septal Myectomy, Cardiac Surgery Involving Left Heart Operation
- Being tested
- Cardiac surgery
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
The TA-BSM group will undergo transapical beating-heart septal myectomy and the group of cardiac surgery involving left heart operation will udergo patients received cardiac surgery involving left heart operation, such as valvuloplasty, valve replacement, repair of auricular septal defect, repair of auricular/ventricular septal defect.
| Study group | Role | What they receive |
|---|---|---|
| TA-BSM | patients received transapical beating-heart septal myectomy Receives: Procedure: Cardiac surgery | |
| Cardiac surgery involving left heart operation | patients received cardiac surgery involving left heart operation, such as valvuloplasty, valve replacement, repair of auricular septal defect, repair of auricular/ventricular septal defect |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of diffusion-weighted MRI lesions
the number (n) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months
Measured: 3 months
The volume of new brain lesions measured by diffusion-weighted MRI
the volume (mL) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months
Measured: 3 months
Secondary outcomes (7)
neurologic injury
The number of participants (n) with neurological events and cognitive dysfunction following transapical beating-heart septal myectomy
Measured: 7 days and 3 months
all-cause and cardiovascular mortality
all-cause and cardiovascular mortality following transapical beating-heart septal myectomy
Measured: 7 days and 3 months
montreal cognitive assessment
montreal cognitive assessment evaluating mild cognitive impairment, ranging from 0 to 30, in which higher scores mean a better outcome.
Measured: 7 days and 3 months
national Institute of Health stroke scale
national Institute of Health stroke scale evaluating mild cognitive impairment, ranging from 0 to 42, in which higher scores mean a worse outcome.
Measured: 7 days and 3 months
modified rankin scale
modified rankin scale evaluating mild cognitive impairment, ranging from 0 to 6, in which higher scores mean a worse outcome.
Measured: 7 days and 3 months
symbol digit modalities test
symbol digit modalities test evaluating mild cognitive impairmentt, ranging from 0 to 90, in which higher scores mean a better outcome.
Measured: 7 days and 3 months
trail-making-test
trail-making-test evaluating mild cognitive impairment, in which the longer time mean a worse outcome.
Measured: 7 days and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic Obstructive Cardiomyopathy \(HOCM\)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang Wei, Tongji Hospital
- Investigators
- Xiang Wei, M.D., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078410
- Sponsor's protocol ID
- 2023-S034
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the conclusive participant data, after removing the individual information of privacy, will be uploaded as supporting information when publishing the current study
Publications
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.
PubMed 31642911
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Neurologic Evaluation in Patients Recevied Transapical Beating-heart Septal Myectomy or General Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06078410
- Acronym / sponsor ID
- 2023-S034
- Conditions
- Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Neurologic Evaluation, Magnetic Resonance Imaging \(MRI\), Transapical Beating-Heart Septal Myectomy, Cardiac Surgery Involving Left Heart Operation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xiang WeiUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TA-BSM | – | Procedure: Cardiac surgerypatients received transapical beating-heart septal myectomy |
| Cardiac surgery involving left heart operation | – | –patients received cardiac surgery involving left heart operation, such as valvuloplasty, valve replacement, repair of auricular septal defect, repair of auricular/ventricular septal defect |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffer from hypertrophic obstructive cardiomyopathy or the other cardiovascular disease and have to receive cardiac surgery involving left heart operation.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeryThe TA-BSM group will undergo transapical beating-heart septal myectomy and the group of cardiac surgery involving left heart operation will udergo patients received cardiac surgery involving left heart operation, such as valvuloplasty, valve replacement, repair of auricular septal defect, repair of auricular/ventricular septal defect. | Procedure or surgery | TA-BSM |
Primary outcome
The incidence of diffusion-weighted MRI lesions
Time frame: 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
Time frame: 3 months
the volume (mL) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months
7 secondary outcomes
neurologic injury
Time frame: 7 days and 3 months
all-cause and cardiovascular mortality
Time frame: 7 days and 3 months
montreal cognitive assessment
Time frame: 7 days and 3 months
national Institute of Health stroke scale
Time frame: 7 days and 3 months
modified rankin scale
Time frame: 7 days and 3 months
symbol digit modalities test
Time frame: 7 days and 3 months
trail-making-test
Time frame: 7 days and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Results publication: PubMed 31642911Fang 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.
- Individual participant dataSharing planned: Yes. All of the conclusive participant data, after removing the individual information of privacy, will be uploaded as supporting information when publishing the current study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiang Wei, M.D. study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Obstructive Cardiomyopathy \(HOCM\) and Neurologic Evaluation, run by Xiang Wei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Wei, M.D. (+8613995525956, xiangwei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of diffusion-weighted MRI lesions (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06078410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.