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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06354413
Other study ID # 2023-2261
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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