Clinical Study of Endocardial Myocardial Biopsy | NCT05718128

Studies
Clinical Study of Endocardial Myocardial Biopsy

NCT05718128

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Recruiting

Last Update Posted

Mar 28, 2023Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Myocarditis
Cardiomyopathies
Heart Failure
Cardiac Tumor
Endocardiomyocardial Biopsy

Interventions

Endocardiomyocardial biopsy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Jun 1, 2031Estimated

Completion Date

Jun 1, 2031Estimated

First Submitted Date

Jun 15, 2021

First Submission Date that Met QC Criteria

Jan 29, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2023

Last Update Posted Date

Mar 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biopsy	Experimental	patients	Procedure: Endocardiomyocardial biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endocardiomyocardial biopsy	Procedure	Endocardiomyocardial biopsy	Biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of MACE-4	incidences of MACE-4(cardiovascular death, myocardial infarction, stroke and hospitalized unstable angina)	10 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
XiaoHong PAN	Contact	+8613857116993		heartpanxh@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Recruiting	Hangzhou	Zhejiang		China

Condition Browse Module

MeSH Terms

ID	Term
D009205	Myocarditis
D009202	Cardiomyopathies
D006333	Heart Failure
D006338	Heart Neoplasms

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided