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NCT Number: NCT04434911

Precision Medicine Study on Cardiovascular Disease (PRECISE)

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.

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Key information

Conditions

Cardiovascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. number of participants with all-cause death

    Time frame: an average of 5 years.

    deaths due to all cause.

Secondary outcomes

  1. number of participants with heart failure

    Time frame: an average of 5 years

    progress to level III or IV in New York Heart Association class.

  2. number of participants with stroke

    Time frame: an average of 5 years

    including cerebral infraction and hemorrhage

  3. number of participants with malignant arrhythmia

    Time frame: an average of 5 years

    including ventricular fibrillation and ventricular tachycardia

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Song, MD.&ph.D

CONTACT

[email protected]

86-13810532620

Lei Song, MD.ph.D

CONTACT

[email protected]

86-18600197655

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Acronym: PRECISE

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
Jun 17, 2020
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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