Myocardial BridgingMB in oHCMNCT06598995
Myocardial Bridging in Obstructive Hypertrophic Cardiomyopathy
An observational study of Myocardial Bridging and Obstructive Hypertrophic Cardiomyopathy, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
This study investigated the impact of myocardial bridging (MB) and its characteristics on preoperative atrial fibrillation and survival in patients with obstructive hypertrophic cardiomyopathy (oHCM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Bridging, Obstructive Hypertrophic Cardiomyopathy, Atrial Fibrillation (AF)
- What is being tested?
- Coronary artery bypass grafting or unroofing
- Type of treatment
- Surgery or procedure
- How many people
- 968 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with obstructive hypertrophic cardiomyopathy who underwent septal myectomy.
Inclusion Criteria:I(i) age ≥ 18 years and (ii) diagnosis of oHCM based on clinical and echocardiographic evaluation.
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Exclusion Criteria: (i) a history of heart surgery (ii) Patients who had coronary atherosclerosis or myocardial infraction; (iii) Patients who had no angiography records.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Myocardial Bridging and Atrial Fibrillation in Patients With Obstructive Hypertrophic Cardiomyopathy
This study investigated the impact of myocardial bridging (MB) and its characteristics on preoperative atrial fibrillation and survival in patients with obstructive hypertrophic cardiomyopathy (oHCM). We recruited 968 consecutive patients with oHCM who underwent myectomy at our institution between January 2015 and December 2019, including 144 patients with MB and 824 patients without MB. All patients received angiography before surgery. The diagnosis of preoperative atrial fibrillation was based on 12-lead electrocardiography, 24-hour Holter electrocardiography, or in-hospital electrocardiogram monitoring, which was extracted from patients' medical records. Surgical details and follow-up data were also collected.
- Being tested
- Coronary artery bypass grafting or unroofing
- Medical subject headings
- Myocardial Bridging, Cardiomyopathy, Hypertrophic, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass grafting or unroofingProcedure or surgery
Patients had an MB with \>75% compression degree would receive coronary artery bypass grafting, and those who underwent unroofing may had a depth of MB \< 5mm (whether deal with these MB with a depth \<5mm depends on the surgeon and the period time of patients received a surgery).
| Study group | Role | What they receive |
|---|---|---|
| Obstructive hypertrophic cardiomyopathy who underwent septal myectomy | All patients underwent angiography and without other coronary artery disease. Receives: Procedure: Coronary artery bypass grafting or unroofing |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Any death occurred one month after discharge
Measured: One month after discharge
Secondary outcomes (2)
New-onset AF
Patients did not have AF before surgery, and AF occurred one month after discharge.
Measured: One month after discharge.
Composite endpoints
Composite endpoints including all-cause death, new-onset AF, and readmission due to heart failure, stroke, and other cardiovascular events (such as myocardial infarction, arrhythmia).
Measured: One month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial BridgingStudies 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
- 968 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changrong Nie, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598995
- Sponsor's protocol ID
- 2022-1892
- Other IDs
- 2022-GSP-GG-29
- Acronym
- MB in oHCM
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Myocardial Bridging and Atrial Fibrillation in Patients With Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06598995
- Acronym / sponsor ID
- MB in oHCM / 2022-1892
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 968 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Sep 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.
This study investigated the impact of myocardial bridging (MB) and its characteristics on preoperative atrial fibrillation and survival in patients with obstructive hypertrophic cardiomyopathy (oHCM). We recruited 968 consecutive patients with oHCM who underwent myectomy at our institution between January 2015 and December 2019, including 144 patients with MB and 824 patients without MB. All patients received angiography before surgery. The diagnosis of preoperative atrial fibrillation was based on 12-lead electrocardiography, 24-hour Holter electrocardiography, or in-hospital electrocardiogram monitoring, which was extracted from patients' medical records. Surgical details and follow-up data were also collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive hypertrophic cardiomyopathy who underwent septal myectomy | – | Procedure: Coronary artery bypass grafting or unroofingAll patients underwent angiography and without other coronary artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with obstructive hypertrophic cardiomyopathy who underwent septal myectomy.
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 |
|---|---|---|
| Coronary artery bypass grafting or unroofingPatients had an MB with \>75% compression degree would receive coronary artery bypass grafting, and those who underwent unroofing may had a depth of MB \< 5mm (whether deal with these MB with a depth \<5mm depends on the surgeon and the period time of patients received a surgery). | Procedure or surgery | Obstructive hypertrophic cardiomyopathy who underwent septal myectomy |
Primary outcome
All-cause death
Time frame: One month after discharge
Any death occurred one month after discharge
2 secondary outcomes
New-onset AF
Time frame: One month after discharge.
Composite endpoints
Time frame: One month after discharge
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 19 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myocardial Bridging and Obstructive Hypertrophic Cardiomyopathy, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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?
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 19 Sep 2024. 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?
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 death (time frame: One month after discharge). 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 19 Sep 2024.