NCT05718128

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
62mo left

Started Jun 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jun 2021Jun 2031

Study Start

First participant enrolled

June 1, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

March 28, 2023

Status Verified

January 1, 2023

Enrollment Period

10 years

First QC Date

June 15, 2021

Last Update Submit

March 26, 2023

Conditions

MyocarditisCardiomyopathiesHeart FailureCardiac TumorEndocardiomyocardial Biopsy

Outcome Measures

Primary Outcomes (1)

  • Incidence of MACE-4

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

    10 year

Study Arms (1)

Biopsy

EXPERIMENTAL

patients

Procedure: Endocardiomyocardial biopsy

Interventions

Endocardiomyocardial biopsyPROCEDURE

Endocardiomyocardial biopsy

Biopsy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

MyocarditisCardiomyopathiesHeart FailureHeart Neoplasms

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesThoracic NeoplasmsNeoplasms by SiteNeoplasms

Central Study Contacts

XiaoHong PAN

CONTACT

+8613857116993heartpanxh@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2021

First Posted

February 8, 2023

Study Start

June 1, 2021

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Last Updated

March 28, 2023

Record last verified: 2023-01

Locations

CN(1)