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Clinical Study of Endocardial Myocardial Biopsy

Primary Purpose

Myocarditis, Cardiomyopathies, Heart Failure

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Endocardiomyocardial biopsy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocarditis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biopsy

Arm Description

patients

Outcomes

Primary Outcome Measures

Incidence of MACE-4
incidences of MACE-4(cardiovascular death, myocardial infarction, stroke and hospitalized unstable angina)

Secondary Outcome Measures

Full Information

First Posted
June 15, 2021
Last Updated
March 26, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05718128
Brief Title
Clinical Study of Endocardial Myocardial Biopsy
Official Title
Clinical Study of Endocardial Myocardial Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2031 (Anticipated)
Study Completion Date
June 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocarditis, Cardiomyopathies, Heart Failure, Cardiac Tumor, Endocardiomyocardial Biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biopsy
Arm Type
Experimental
Arm Description
patients
Intervention Type
Procedure
Intervention Name(s)
Endocardiomyocardial biopsy
Intervention Description
Endocardiomyocardial biopsy
Primary Outcome Measure Information:
Title
Incidence of MACE-4
Description
incidences of MACE-4(cardiovascular death, myocardial infarction, stroke and hospitalized unstable angina)
Time Frame
10 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XiaoHong PAN
Phone
+8613857116993
Email
heartpanxh@163.com
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XiaoHong PAN

12. IPD Sharing Statement

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Clinical Study of Endocardial Myocardial Biopsy

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