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
About this trial
This is an interventional diagnostic trial for Myocarditis
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.
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
NCT ID
NCT05718128
First Posted
June 15, 2021
Last Updated
March 26, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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
Learn more about this trial
Clinical Study of Endocardial Myocardial Biopsy
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