Myocardial Bridging in Obstructive Hypertrophic Cardiomyopathy (MB in oHCM)

September 12, 2024 updated by: Changrong Nie, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

968

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Please Select
      • Beijing, Please Select, China, 475
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with obstructive hypertrophic cardiomyopathy who underwent septal myectomy.

Description

Inclusion Criteria:I(i) age ≥ 18 years and (ii) diagnosis of oHCM based on clinical and echocardiographic evaluation.

-

Exclusion Criteria: (i) a history of heart surgery (ii) Patients who had coronary atherosclerosis or myocardial infraction; (iii) Patients who had no angiography records.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obstructive hypertrophic cardiomyopathy who underwent septal myectomy
All patients underwent angiography and without other coronary artery disease.
Procedure: Coronary artery bypass grafting or unroofing
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: One month after discharge
Any death occurred one month after discharge
One month after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New-onset AF
Time Frame: One month after discharge.
Patients did not have AF before surgery, and AF occurred one month after discharge.
One month after discharge.
Composite endpoints
Time Frame: One month after discharge
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).
One month after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1892
  • 2022-GSP-GG-29 (Other Grant/Funding Number: National High Level Hospital Clinical Research Funding)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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