Precision Medicine Study on Cardiovascular Disease (PRECISE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20,000
- Locations
- 1
- Primary Endpoint
- number of participants with cardiovascular deaths
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
number of participants with cardiovascular deaths
Time Frame: an average of 5 years
including sudden cardiac death and deaths due to heart failure and stroke.
number of participants with all-cause death
Time Frame: an average of 5 years.
deaths due to all cause.
Secondary Outcomes
- number of participants with stroke(an average of 5 years)
- number of participants with malignant arrhythmia(an average of 5 years)
- number of participants with heart failure(an average of 5 years)
Investigators
Lei.Song@NCCD
Principal Investigator
China National Center for Cardiovascular Diseases