<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/NCT03752515</url>
  </required_header>
  <id_info>
    <org_study_id>BeijingIHLBVD2018010</org_study_id>
    <nct_id>NCT03752515</nct_id>
  </id_info>
  <brief_title>A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome</brief_title>
  <acronym>ARSGB-ACS</acronym>
  <official_title>A Chinese Registry to Determine the Genetics Risk Factors and Serumal Biomarkers for Acute Coronary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Institute of Heart, Lung and Blood Vessel Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Institute of Heart, Lung and Blood Vessel 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>
      This is a national registry study to determine genetics risk factors and serial biomarkers of&#xD;
      Acute Coronary Syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2, 2015</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Age for each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender for each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Height for each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight for each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Contact information for each participant</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Past Medical History including disease history, surgical history, and family medical history</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lifestyle including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day</measure>
    <time_frame>These data is collected from the cases' medical record in an average of 1 month after the sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Exon sequencing data of each participant</measure>
    <time_frame>Sequencing will be carried out in an average of 3 months after sample recruiting</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of serum sample.</measure>
    <time_frame>The data is collected from lab in an average of 3 month after the sample recruiting</time_frame>
    <description>The results of metabolomics will be measured by mass spectrometry, including lipids, sugars, amino acids, carnitine, choline, arachidonic acid, sterol and free fat acid . All of metabolites will be quantitative (unit: mol/L). Identification of molecules via Human Metabolites Database will be reported online.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection of miRNAs expression in each participant using the qRT-PCT method.</measure>
    <time_frame>The data is collected from lab in an average of 3 month after the sample recruiting</time_frame>
    <description>Relative expression levels of miRNA were analyzed using the 2-△Ct method and U6 was used as an endogenous control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Major adverse cardiovascular events (MACE) in overall population, defined as composite of all-cause death, Heart Failure hospitalization, recurrent myocardial infarction, stroke or ischemia-driven revascularization.</measure>
    <time_frame>These data is collected during follow-up visit at 3/6/12/24/36 months after discharge</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Unstable Angina</condition>
  <arm_group>
    <arm_group_label>case</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable&#xD;
      cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA.&#xD;
&#xD;
      If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid&#xD;
      nitrogen.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        case group consists of patients who was diagnosed as Acute Coronary Syndrome. control group&#xD;
        is general population without Acute Coronary Syndrome.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Case Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent has been provided.&#xD;
&#xD;
          -  Contact Order Form has been provided.&#xD;
&#xD;
          -  Aged 18 years or older.&#xD;
&#xD;
          -  Hospitalized within 48 hours of onset of symptoms.&#xD;
&#xD;
          -  Diagnosis of STEMI, NSTEMI or UA using the following definitions:&#xD;
&#xD;
             1.Criteria for STEMI diagnosis:&#xD;
&#xD;
               1. History of chest pain/discomfort and&#xD;
&#xD;
               2. Persistent ST-segment elevation (&gt; 30 min) of ≥ 0.1 mV in 2 or more contiguous&#xD;
                  ECG leads or presumed new left bundle branch block (LBBB) on admission and&#xD;
&#xD;
               3. Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the&#xD;
                  99th percentile of the local laboratory upper reference limit.&#xD;
&#xD;
             2.Criteria for NSTEMI diagnosis:&#xD;
&#xD;
             1.History of chest pain/discomfort and 2.Lack of persistent ST-segment elevation, LBBB&#xD;
             or intraventricular conduction disturbances and 3.Elevation of cardiac biomarkers&#xD;
             (CK-MB, troponins): at least one value above the 99th percentile of the local&#xD;
             laboratory upper reference limit. 3.Criteria for Unstable Angina diagnosis:&#xD;
&#xD;
               1. Symptoms of angina at rest or on minimal exercise and&#xD;
&#xD;
               2. At least 0.5mm ST deviation in at least 2 leads and&#xD;
&#xD;
               3. No increase in biomarkers of necrosis&#xD;
&#xD;
               4. OR objective evidence of ischaemia by non-invasive imaging OR significant&#xD;
                  coronary stenosis as determined by the treating physician at angiography if this&#xD;
                  is standard practice in study site.&#xD;
&#xD;
                  Case Exclusion Criteria:&#xD;
&#xD;
                  Patients will not be eligible to participate if any of the following exclusion&#xD;
                  criteria are present:&#xD;
&#xD;
          -  UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI&#xD;
             bleeding or post-PCI.&#xD;
&#xD;
          -  UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.&#xD;
&#xD;
          -  Presence of any condition/circumstance which in the opinion of the investigator could&#xD;
             significantly limit the complete follow up of the patient (e.g. tourist, non-native&#xD;
             speaker or does not understand the local language, psychiatric disturbances).&#xD;
&#xD;
          -  Presence of serious/severe co-morbidities in the opinion of the investigator which may&#xD;
             limit short term (i.e. 6 month) life expectancy.&#xD;
&#xD;
          -  Current participation in a randomised interventional clinical trial.&#xD;
&#xD;
        Control Inclusion Criteria:&#xD;
&#xD;
          -  Age and gender are matched with cases.&#xD;
&#xD;
          -  No Coronary Artery Disease was detected by Coronary CT examination.&#xD;
&#xD;
          -  Normal biochemical indicators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Du, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Beijing Anzhen Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yulin Li, PHD</last_name>
    <email>lyllyl_1111@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ke-xu Yang</last_name>
      <phone>86-010-64426153</phone>
      <email>EC@anzhenGCP.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Luhe Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fuli Zhu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongkui Ren</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lijiao Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Jilin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoyu Du</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>December 31, 2019</last_update_submitted>
  <last_update_submitted_qc>December 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Angina, Unstable</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Infarction</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/NCT03752515
org study id: BeijingIHLBVD2018010
nct id: NCT03752515
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a national registry study to determine genetics risk factors and serial biomarkers of
      Acute Coronary Syndrome.
observational model: Cohort
time perspective: Prospective
measure: Age for each participant
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Gender for each participant
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Height for each participant
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Weight for each participant
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Contact information for each participant
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Past Medical History including disease history, surgical history, and family medical history
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Lifestyle including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day
time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Exon sequencing data of each participant
time frame: Sequencing will be carried out in an average of 3 months after sample recruiting
measure: Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of serum sample.
time frame: The data is collected from lab in an average of 3 month after the sample recruiting
description: The results of metabolomics will be measured by mass spectrometry, including lipids, sugars, amino acids, carnitine, choline, arachidonic acid, sterol and free fat acid . All of metabolites will be quantitative (unit: mol/L). Identification of molecules via Human Metabolites Database will be reported online.
measure: Detection of miRNAs expression in each participant using the qRT-PCT method.
time frame: The data is collected from lab in an average of 3 month after the sample recruiting
description: Relative expression levels of miRNA were analyzed using the 2-△Ct method and U6 was used as an endogenous control.
measure: Major adverse cardiovascular events (MACE) in overall population, defined as composite of all-cause death, Heart Failure hospitalization, recurrent myocardial infarction, stroke or ischemia-driven revascularization.
time frame: These data is collected during follow-up visit at 3/6/12/24/36 months after discharge
arm group label: case
arm group label: control
If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable
      cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA.

      If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid
      nitrogen.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jie Du, PHD
role: Study Director
affiliation: Beijing Anzhen Hospital
last name: Yulin Li, PHD
email: lyllyl_1111@163.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Angina, Unstable
mesh term: Syndrome
mesh term: Infarction
sharing ipd: Undecided