Precision Medicine Study on Cardiovascular Disease (PRECISE)

Cardiovascular Diseases Clinical Trial

— PRECISE  

Official title:

Precision Medicine Study on Cardiovascular Disease (PRECISE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04434911
• Other study ID #: PRECISE
• Status: Not yet recruiting
• Start date: March 10, 2021
• Est. completion date: October 10, 2030

Study information

• Verified date: March 2021
• Source: China National Center for Cardiovascular Diseases
• Contact: Lei Song, MD.&ph.D
• Phone: 86-13810532620
• Email: clinicalfw[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: October 10, 2030
• Est. primary completion date: October 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with cardiovascular deaths	including sudden cardiac death and deaths due to heart failure and stroke.	an average of 5 years
Primary	number of participants with all-cause death	deaths due to all cause.	an average of 5 years.
Secondary	number of participants with heart failure	progress to level III or IV in New York Heart Association class.	an average of 5 years
Secondary	number of participants with stroke	including cerebral infraction and hemorrhage	an average of 5 years
Secondary	number of participants with malignant arrhythmia	including ventricular fibrillation and ventricular tachycardia	an average of 5 years