Cardiovascular DiseasesPRECISENCT04434911
Precision Medicine Study on Cardiovascular Disease (PRECISE)
An observational study of Cardiovascular Diseases, run by China National Center for Cardiovascular Diseases at 1 site in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2021to 10 Oct 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with monogenic cardiovascular disease from multiple centers in China between October 10, 2020 and October 10, 2025
Who may be able to join
- Patients with monogenic cardiovascular diagnosed according current practice guideline.
Who cannot join
- Patients who refuse to sign the informed consent or decline follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Keywords
- monogenic cardiovascular disease, clinical outcomes, genomics, genetic diagnosis, risk stratification
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with cardiovascular deaths
including sudden cardiac death and deaths due to heart failure and stroke.
Measured: an average of 5 years
number of participants with all-cause death
deaths due to all cause.
Measured: an average of 5 years.
Secondary outcomes (3)
number of participants with heart failure
progress to level III or IV in New York Heart Association class.
Measured: an average of 5 years
number of participants with stroke
including cerebral infraction and hemorrhage
Measured: an average of 5 years
number of participants with malignant arrhythmia
including ventricular fibrillation and ventricular tachycardia
Measured: an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start10 Mar 2021 (estimated)
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lei.Song@NCCD, China National Center for Cardiovascular Diseases
- Investigators
- Lei Song, MD. ph.D, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434911
- Sponsor's protocol ID
- PRECISE
- Acronym
- PRECISE
- Status last verified
- Mar 2021
- First submitted
- 15 Jun 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine Study on Cardiovascular Disease (PRECISE)
- ClinicalTrials.gov ID
- NCT04434911
- Acronym / sponsor ID
- PRECISE / PRECISE
- Conditions
- Cardiovascular Diseases
- Keywords
- monogenic cardiovascular disease, clinical outcomes, genomics, genetic diagnosis, risk stratification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 10 Mar 2021 (estimated)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Oct 2030 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with monogenic cardiovascular disease from multiple centers in China between October 10, 2020 and October 10, 2025
Key inclusion criteria (1 listed)
- Patients with monogenic cardiovascular diagnosed according current practice guideline.
Key exclusion criteria (1 listed)
- Patients who refuse to sign the informed consent or decline follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Song, MD. ph.D principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Song, MD.&ph.D (86-13810532620, clinicalfw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with cardiovascular deaths (time frame: an average of 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.