Precision Medicine Study on Cardiovascular Disease (PRECISE)

Not yet recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT04434911
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

In this study, patients with monogenic cardiovascular disease are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography, MRI and other examinations if necessary. The specimens retained include blood, saliva, urine and feces for all patients, and myocardium for patients receive cardio myectomy surgery . Genetic testing will be performed to identify novel disease genes, genetic risk factors and potential therapy targets.

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-17
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-07
• Last Update Posted: 2021-03-09
• Study Start: 2021-03-10
• Primary Completion: 2025-10-10
• Study Completion: 2030-10-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Patients with monogenic cardiovascular diagnosed according current practice guideline.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of participants with cardiovascular deaths	an average of 5 years	including sudden cardiac death and deaths due to heart failure and stroke.
number of participants with all-cause death	an average of 5 years.	deaths due to all cause.

Secondary Outcome Measures

Name	Time	Method
number of participants with stroke	an average of 5 years	including cerebral infraction and hemorrhage
number of participants with malignant arrhythmia	an average of 5 years	including ventricular fibrillation and ventricular tachycardia
number of participants with heart failure	an average of 5 years	progress to level III or IV in New York Heart Association class.

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China