Outcomes of Concomitant Bypass Surgery in Septal Myectomy

Coronary Artery Disease Clinical Trial

Official title:

Establishing a Database of Patients Undergoing Surgery for Hypertrophic Cardiomyopathy (Concomitant Bypass Surgery)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06354413
• Other study ID #: 2023-2261
• Status: Completed
• Start date: January 2009
• Est. completion date: December 2023

Study information

• Verified date: April 2024
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 2023
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Coronary Artery Disease
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Myocardial Bridging

Intervention

Procedure:
• CABG during myectomy
To explore the effect of CABG during myectomy. No control group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	death because of any reason	through study completion, an average of 5 year
Secondary	cardiac-related deaths and readmission	deaths and readmission because of heart failure, stoke, and etc.	through study completion, an average of 5 year