<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04434911</url>
  </required_header>
  <id_info>
    <org_study_id>PRECISE</org_study_id>
    <nct_id>NCT04434911</nct_id>
  </id_info>
  <brief_title>Precision Medicine Study on Cardiovascular Disease (PRECISE)</brief_title>
  <acronym>PRECISE</acronym>
  <official_title>Precision Medicine Study on Cardiovascular Disease (PRECISE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China National Center for Cardiovascular Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China National Center for Cardiovascular Diseases</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular diseases are the leading cause of death in China and have become a financial&#xD;
      burden on society under the traditional medical model. A new and sustainable medical model is&#xD;
      needed to solve this dilemma, for which precision medicine models have great potential.&#xD;
      Monogenic cardiovascular disease is the first field to be broken through in precision&#xD;
      medicine at this stage, and it is also the field where precision medicine is most likely to&#xD;
      be successfully transformed into clinical application, including genetic diagnosis, molecular&#xD;
      typing, risk stratification, genetic interruption and individualized treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, patients with monogenic cardiovascular disease are recruited prospectively&#xD;
      after informed consent was given. The investigator will collect the baseline clinical&#xD;
      characteristics of the patients at enrollment, including comprehensive physical examination,&#xD;
      laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography,&#xD;
      MRI and other examinations if necessary. The specimens retained include blood, saliva, urine&#xD;
      and feces for all patients, and myocardium for patients receive cardio myectomy surgery .&#xD;
      Genetic testing will be performed to identify novel disease genes, genetic risk factors and&#xD;
      potential therapy targets.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">March 10, 2021</start_date>
  <completion_date type="Anticipated">October 10, 2030</completion_date>
  <primary_completion_date type="Anticipated">October 10, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>number of participants with cardiovascular deaths</measure>
    <time_frame>an average of 5 years</time_frame>
    <description>including sudden cardiac death and deaths due to heart failure and stroke.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of participants with all-cause death</measure>
    <time_frame>an average of 5 years.</time_frame>
    <description>deaths due to all cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of participants with heart failure</measure>
    <time_frame>an average of 5 years</time_frame>
    <description>progress to level III or IV in New York Heart Association class.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants with stroke</measure>
    <time_frame>an average of 5 years</time_frame>
    <description>including cerebral infraction and hemorrhage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants with malignant arrhythmia</measure>
    <time_frame>an average of 5 years</time_frame>
    <description>including ventricular fibrillation and ventricular tachycardia</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20000</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Specimens retained include blood, saliva, urine, feces, and myocardium when the patients&#xD;
      receive cardio myectomy surgery.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with monogenic cardiovascular disease from multiple centers in China between&#xD;
        October 10, 2020 and October 10, 2025&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with monogenic cardiovascular diagnosed according current practice guideline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse to sign the informed consent or decline follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lei Song, MD. ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fuwai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Song, MD.&amp;ph.D</last_name>
    <phone>86-13810532620</phone>
    <email>clinicalfw@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lei Song, MD.ph.D</last_name>
    <phone>86-18600197655</phone>
    <email>clinicalfw@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fuwai hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>March 7, 2021</last_update_submitted>
  <last_update_submitted_qc>March 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China National Center for Cardiovascular Diseases</investigator_affiliation>
    <investigator_full_name>Lei.Song@NCCD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>monogenic cardiovascular disease</keyword>
  <keyword>clinical outcomes</keyword>
  <keyword>genomics</keyword>
  <keyword>genetic diagnosis</keyword>
  <keyword>risk stratification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434911
org study id: PRECISE
nct id: NCT04434911
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: number of participants with cardiovascular deaths
time frame: an average of 5 years
description: including sudden cardiac death and deaths due to heart failure and stroke.
measure: number of participants with all-cause death
time frame: an average of 5 years.
description: deaths due to all cause.
measure: number of participants with heart failure
time frame: an average of 5 years
description: progress to level III or IV in New York Heart Association class.
measure: number of participants with stroke
time frame: an average of 5 years
description: including cerebral infraction and hemorrhage
measure: number of participants with malignant arrhythmia
time frame: an average of 5 years
description: including ventricular fibrillation and ventricular tachycardia
Specimens retained include blood, saliva, urine, feces, and myocardium when the patients
      receive cardio myectomy surgery.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lei Song, MD. ph.D
role: Principal Investigator
affiliation: Fuwai Hospital
last name: Lei Song, MD.&ph.D
phone: 86-13810532620
email: clinicalfw@163.com
last name: Lei Song, MD.ph.D
phone: 86-18600197655
email: clinicalfw@163.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China National Center for Cardiovascular Diseases
investigator full name: Lei.Song@NCCD
investigator title: Principal Investigator
mesh term: Cardiovascular Diseases
sharing ipd: Undecided