Hypertrophic CardiomyopathyNCT06354413
Outcomes of Concomitant Bypass Surgery in Septal Myectomy
An observational study of Hypertrophic Cardiomyopathy and Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial summary
To investigate clinical characteristics and survival outcomes of patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting during septal myectomy. Read more about this study
- Who is it for?
- Ages 8 to 90 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Coronary Artery Disease, Myocardial Bridging
- What is being tested?
- CABG during myectomy
- Type of treatment
- Surgery or procedure
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2023
- 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 8 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting(due to atherosclerosis coronary artery diseases or myocardial bridge) during septal myectomy.
Who may be able to join
- Clinical diagnosis of obstructive hypertrophic cardiomyopathy.
- Undergo ventricular septal resection and cardiac bypass surgery at the same time.
Who cannot join
- Incomplete surgical and follow-up data
About this study
Official title: Establishing a Database of Patients Undergoing Surgery for Hypertrophic Cardiomyopathy (Concomitant Bypass Surgery)
To investigate clinical characteristics and survival outcomes of patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting during septal myectomy.
Read the detailed description
Surgical septal myectomy (SM) is an effective approach for treating patients with drug-refractory obstructive hypertrophic cardiomyopathy (HCM).However, numerous patients with HCM exhibit concurrent ischemic heart disease, including atherosclerotic coronary artery disease (CAD) and myocardial bridging (MB). Although patients with HCM have been known to possess diminished coronary flow reserve,additional CAD can worsen myocardial ischemia, contributing to an unfavorable prognosis.MB, although infrequent, may affect diastolic heart perfusion, leading to angina and even sudden death.Current guidelines recommend revascularization for ischemic heart disease caused by CAD and MB.However, the impact of concomitant coronary revascularization during HCM management remains unclear. In this study, we analyzed the clinical characteristics and surgical scenarios of patients who underwent concomitant coronary artery bypass grafting (CABG) during ventricular SM and investigated their prognosis.
Patient clinical and survival data from 2009-2020 were retrospectively reviewed. The median follow-up period was 5.1 years. All-cause mortality was the primary endpoint.
- Being tested
- CABG during myectomy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Coronary Artery Disease, Myocardial Bridging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABG during myectomyProcedure or surgery
To explore the effect of CABG during myectomy. No control group
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
death because of any reason
Measured: through study completion, an average of 5 year
Secondary outcomes (1)
cardiac-related deaths and readmission
deaths and readmission because of heart failure, stoke, and etc.
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study startJan 2009
- Primary completionDec 2020
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuiyun Wang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Tao Lu, MD, Study director, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354413
- Sponsor's protocol ID
- 2023-2261
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Database of Patients Undergoing Surgery for Hypertrophic Cardiomyopathy (Concomitant Bypass Surgery)
- ClinicalTrials.gov ID
- NCT06354413
- Acronym / sponsor ID
- 2023-2261
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 9 Apr 2024 (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.
To investigate clinical characteristics and survival outcomes of patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting during septal myectomy.
Detailed description
Surgical septal myectomy (SM) is an effective approach for treating patients with drug-refractory obstructive hypertrophic cardiomyopathy (HCM).However, numerous patients with HCM exhibit concurrent ischemic heart disease, including atherosclerotic coronary artery disease (CAD) and myocardial bridging (MB). Although patients with HCM have been known to possess diminished coronary flow reserve,additional CAD can worsen myocardial ischemia, contributing to an unfavorable prognosis.MB, although infrequent, may affect diastolic heart perfusion, leading to angina and even sudden death.Current guidelines recommend revascularization for ischemic heart disease caused by CAD and MB.However, the impact of concomitant coronary revascularization during HCM management remains unclear. In this study, we analyzed the clinical characteristics and surgical scenarios of patients who underwent concomitant coronary artery bypass grafting (CABG) during ventricular SM and investigated their prognosis.
Patient clinical and survival data from 2009-2020 were retrospectively reviewed. The median follow-up period was 5.1 years. All-cause mortality was the primary endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with obstructive hypertrophic cardiomyopathy who underwent concomitant coronary artery bypass grafting(due to atherosclerosis coronary artery diseases or myocardial bridge) during septal myectomy.
Key inclusion criteria (2 listed)
- Clinical diagnosis of obstructive hypertrophic cardiomyopathy.
- Undergo ventricular septal resection and cardiac bypass surgery at the same time.
Key exclusion criteria (1 listed)
- Incomplete surgical and follow-up data
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 |
|---|---|---|
| CABG during myectomyTo explore the effect of CABG during myectomy. No control group | Procedure or surgery | – |
Primary outcome
all-cause mortality
Time frame: through study completion, an average of 5 year
death because of any reason
1 secondary outcome
cardiac-related deaths and readmission
Time frame: through study completion, an average of 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Tao Lu, MD study director
Chinese Academy of Medical Sciences, Fuwai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy and Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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 2 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: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: through study completion, an average of 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2024.