Menu
Not yet recruiting NCT04434911

Precision Medicine Study on Cardiovascular Disease (PRECISE)

Observational Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • number of participants with cardiovascular deaths [Time frame: an average of 5 years]
  • number of participants with all-cause death [Time frame: an average of 5 years.]
Secondary outcome measures (3)
  • number of participants with heart failure [Time frame: an average of 5 years]
  • number of participants with stroke [Time frame: an average of 5 years]
  • number of participants with malignant arrhythmia [Time frame: an average of 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fuwai hospital — Beijing

Identifiers

NCT: NCT04434911 · PRECISE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗