Clinical Study of Endocardial Myocardial Biopsy

Heart Failure Clinical Trial

Official title:

Clinical Study of Endocardial Myocardial Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718128
• Other study ID #: 2021-0131
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: June 1, 2031

Study information

• Verified date: January 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: XiaoHong PAN
• Phone: +8613857116993
• Email: heartpanxh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, patients with endocardial myocardial biopsy were selected to observe the safety of the operation, and pathological examination was performed. If necessary, special tests such as viral examination, mass spectrometry and molecular biology were performed to confirm the diagnosis, and follow-up was performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2031
• Est. primary completion date: June 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with no gender restriction, age 18-80 years old, receiving endocardial myocardial biopsy in the Second Affiliated Hospital of Zhejiang University School of Medicine;
• Patients with myocarditis, cardiomyopathy, heart failure and cardiac tumor of unknown clinical cause;
• Have the ability to understand the test, can cooperate with investigators.

Exclusion Criteria:

• Unable to understand or unwilling to fill in informed consent forms or follow visitors.

Related Conditions & MeSH terms

• Cardiac Tumor
• Cardiomyopathies
• Heart Failure
• Myocarditis

Intervention

Procedure:
• Endocardiomyocardial biopsy
Endocardiomyocardial biopsy

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of MACE-4	incidences of MACE-4(cardiovascular death, myocardial infarction, stroke and hospitalized unstable angina)	10 year