Outcomes of Concomitant Bypass Surgery in Septal Myectomy

April 5, 2024 updated by: Shuiyun Wang, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

320

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  1. Clinical diagnosis of obstructive hypertrophic cardiomyopathy.
  2. Undergo ventricular septal resection and cardiac bypass surgery at the same time.

Exclusion Criteria:

Incomplete surgical and follow-up data

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: through study completion, an average of 5 year
death because of any reason
through study completion, an average of 5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac-related deaths and readmission
Time Frame: through study completion, an average of 5 year
deaths and readmission because of heart failure, stoke, and etc.
through study completion, an average of 5 year

Collaborators and Investigators

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

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Study Director: Tao Lu, MD, 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, 2009

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-2261

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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