Actively Recruiting
Clinical Study of Endocardial Myocardial Biopsy
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2023-03-28
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of endocardial myocardial biopsy in patients with heart conditions such as myocarditis, cardiomyopathy, heart failure, and cardiac tumors of unknown cause. This clinical study aims to observe the operation's safety and perform pathological examinations, including special tests like viral examination, mass spectrometry, and molecular biology, to confirm diagnoses. The study is led by the Second Affiliated Hospital, School of Medicine, Zhejiang University and is a phase 4 interventional trial. The study involves patients undergoing the endocardial myocardial biopsy procedure, which is being assessed for safety and diagnostic value. If necessary, additional specialized tests are performed on biopsy samples to better understand the underlying cardiac condition. Participants are those who receive this biopsy procedure at the hospital and meet the study's eligibility criteria. During the study, researchers will follow participants over time to monitor safety and outcomes, including the incidence of major adverse cardiovascular events (MACE-4) over a 10-year period. Participants will be observed and assessed through pathological examinations and follow-up visits. The study began in June 2021 and is planned to continue until June 2031, providing long-term safety data.
CONDITIONS
Brief Title
Clinical Study of Endocardial Myocardial Biopsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of any gender aged 18 to 80 years old receiving endocardial myocardial biopsy at the Second Affiliated Hospital of Zhejiang University School of Medicine
- Diagnosed with myocarditis, cardiomyopathy, heart failure, or cardiac tumor of unknown clinical cause
- Able to understand the test and cooperate with study investigators
You will not qualify if you...
- Unable or unwilling to understand or sign informed consent forms
- Unable or unwilling to attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo an endocardiomyocardial biopsy to assess their heart condition.
1 visit (in-person)
Duration - 10 years
Participants are monitored for major adverse cardiac events (MACE) over a period of 10 years after the biopsy.
Follow-up visits over 10 years
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
X
XiaoHong PAN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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