NCT04434911

Brief Summary

Cardiovascular diseases are the leading cause of death in China and have become a financial burden on society under the traditional medical model. A new and sustainable medical model is needed to solve this dilemma, for which precision medicine models have great potential. Monogenic cardiovascular disease is the first field to be broken through in precision medicine at this stage, and it is also the field where precision medicine is most likely to be successfully transformed into clinical application, including genetic diagnosis, molecular typing, risk stratification, genetic interruption and individualized treatment.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Mar 2021Oct 2030

First Submitted

Initial submission to the registry

June 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2030

Expected
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

4.6 years

First QC Date

June 15, 2020

Last Update Submit

March 7, 2021

Conditions

Keywords

monogenic cardiovascular diseaseclinical outcomesgenomicsgenetic diagnosisrisk stratification

Outcome Measures

Primary Outcomes (2)

  • number of participants with cardiovascular deaths

    including sudden cardiac death and deaths due to heart failure and stroke.

    an average of 5 years

  • number of participants with all-cause death

    deaths due to all cause.

    an average of 5 years.

Secondary Outcomes (3)

  • number of participants with heart failure

    an average of 5 years

  • number of participants with stroke

    an average of 5 years

  • number of participants with malignant arrhythmia

    an average of 5 years

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with monogenic cardiovascular disease from multiple centers in China between October 10, 2020 and October 10, 2025

You may qualify if:

  • Patients with monogenic cardiovascular diagnosed according current practice guideline.

You may not qualify if:

  • Patients who refuse to sign the informed consent or decline follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Specimens retained include blood, saliva, urine, feces, and myocardium when the patients receive cardio myectomy surgery.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Lei Song, MD. ph.D

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Song, MD.&ph.D

CONTACT

Lei Song, MD.ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 17, 2020

Study Start

March 10, 2021

Primary Completion

October 10, 2025

Study Completion (Estimated)

October 10, 2030

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations