Study on Standard Evaluation System and Optimal Treatment Path of Senile Valvular Heart Disease

NCT ID: NCT05044338

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-11-30

Brief Summary

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The key technology research and standard evaluation system of elderly heart valve disease evaluation is to further establish a domestic multi center and large sample full information big data platform of elderly heart valve disease based on the previous Chinese elderly valve disease cohort and clinical research platform and the national valve disease surgery data platform.

Detailed Description

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Establish clinical and Imaging Database

Conditions

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Valvular Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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imaging

(1) Build the first full information big data cloud platform for diagnosis, treatment and clinical research of senile valvular disease in China (2) To establish a cohort of elderly patients with valvular disease in China and a complete database covering clinical information, functional, imaging evaluation, treatment and follow-up; (3) To analyze the clinical characteristics, functional status and imaging characteristics of senile valvular disease in China, and to understand the current situation of diagnosis and treatment; To establish a whole process standardized comprehensive evaluation system of clinical indicators of senile valvular disease combined with a variety of imaging for Chinese people.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Patients with heart valve disease who are ≥ 65 years old and diagnosed by echocardiography meet the requirements

One of the following criteria:

* (1)Severe mitral stenosis: valve orifice area \< 1.0cm2;
* (2)Severe mitral regurgitation: constriction neck width ≥ 7mm, or regurgitation per beat (regurgitation volume)≥ 60ml, or reflux beam area / left atrial area \> 50%; Or effective reflux port area (eroa) ≥ 0.4cm2;
* (3)Severe aortic stenosis: mean cross valve pressure difference ≥ 40mmhg, or maximum jet velocity ≥ 4m / s, orValve orifice area \< 1.0cm2, it should be differentiated from left ventricular outflow tract stenosis;
* (4)Severe aortic regurgitation: constriction neck width \> 6mm, or each pulsation regurgitation ≥ 60ml, or regurgitation Flow fraction ≥ 50%, or jet width ≥ 65% of left ventricular outflow tract, or effective reflux orifice area (eroa) ≥0.3cm2;
* (5)Severe tricuspid stenosis: mean cross valve pressure difference ≥ 5mmhg;
* (6)Severe tricuspid regurgitation: constriction neck width ≥ 7mm, or effective regurgitation orifice area (eroa)≥0.4cm2;
* (7)Severe pulmonary stenosis: the forward blood flow velocity is ≥ 4m / s, which should be differentiated from right ventricular outflow tract stenosis; Severe pulmonary valve regurgitation: massive regurgitation, wide constriction neck

Exclusion Criteria

* Patients unwilling to accept registration and follow-up;
* Patients with mental illness who cannot cooperate with information collection and follow-up
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yongjian Wu

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yongjian Wu

Chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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yongjian wu, doctor

Role: STUDY_CHAIR

Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences

Locations

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Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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haiyan xu, doctor

Role: CONTACT

+86 13681012249

Facility Contacts

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haiyan xu, doctor

Role: primary

+86 13681012249

yongjian wu, doctor

Role: backup

+86 13701387189

Other Identifiers

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2020YFC2008100

Identifier Type: -

Identifier Source: org_study_id

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