<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/NCT02967718</url>
  </required_header>
  <id_info>
    <org_study_id>2014CB542903</org_study_id>
    <nct_id>NCT02967718</nct_id>
  </id_info>
  <brief_title>Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome</brief_title>
  <official_title>Clinical Observation of CHD Phlegm and Blood-stasis Syndrome Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jingqing Hu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronary heart disease is still the major cause of death in China. Chinese medicine plays&#xD;
      more and more important role in CHD prevention and treatment. Phlegm and blood stasis are its&#xD;
      major pathological basis. Based on that, the investigator aims to evaluate the evolutionary&#xD;
      process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section&#xD;
      observation combining with longitudinal tracking on-site survey method so as to guide the&#xD;
      clinical treatment of CHD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary heart disease (CHD) is a major cause of myocardial infarct (MI) and death induced by&#xD;
      atherosclerosis or coronary artery spasm. Despite improvements in interventional and&#xD;
      pharmacological therapy for acute MI, the mortality early after AMI remains high. Nowadays,&#xD;
      as our life quality develops and dietary structure changes, the morbidity of hyperlipidemia&#xD;
      dramatically increased. Based on the Chinese medicine, hyperlipidemia belongs to phlegm and&#xD;
      it's the basis of atherosclerosis, blood-stasis is the pathological basis of ischemia.&#xD;
      Therefore, the investigator proposes that phlegm and blood-stasis syndrome is the main&#xD;
      differentiation on CHD. Based on that, the investigator prospectively and retrospectively&#xD;
      explores the evolutionary process of CHD phlegm-blood stasis syndrome by large samples,&#xD;
      multi-centre, cross-section observation combining with longitudinal tracking on-site survey&#xD;
      method.It will provide evidence and guidance to the future clinical treatment using Chinese&#xD;
      medicine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>all cause mortality</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">13000</enrollment>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>the healthy patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metabolic syndrome group</arm_group_label>
    <description>Include patients who are accordance with diagnostic criteria of metabolic syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHD stable stage group</arm_group_label>
    <description>Include patients who are accordance with diagnostic criteria of asymptomatic angina, stable angina or stable (more than 1 month) acute coronary syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute coronary syndrome group</arm_group_label>
    <description>Include patients who are accordance with diagnostic criteria of unstable angina or non-ST-segment elevated myocardial infarction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCI or CABG group</arm_group_label>
    <description>Include the patients who will undergo percutaneous coronary intervention of coronary artery bypass grafting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHD heart failure group</arm_group_label>
    <description>Include the patients who suffered heart failure cause by CHD</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy, metabolic or coronary heart disease people, whose age is between 35-85 years old,&#xD;
        either female or male, without any inflammation, fever, trauma, burn or operation within 1&#xD;
        week.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy or metabolism syndrome people&#xD;
&#xD;
          -  Clinical diagnosis of CHD stable stage or acute coronary disease or CHD heart failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any inflammation, fever, trauma, burn or operation within 1 week&#xD;
&#xD;
          -  Obstructive pulmonary disease&#xD;
&#xD;
          -  Cerebral vascular disease&#xD;
&#xD;
          -  Severe renal or hepatic dysfunction&#xD;
&#xD;
          -  Malignant neoplasms&#xD;
&#xD;
          -  Hematopoietic system disease&#xD;
&#xD;
          -  Sever mental disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Weiming Xu, Doctor</last_name>
    <phone>86-15652608470</phone>
    <email>dreameng2008@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Integrative Hospital of Beijing</name>
      <address>
        <city>Beijin</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanhui Wang</last_name>
      <phone>86-15810821765</phone>
      <email>yhuiwang@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 20, 2016</last_update_submitted>
  <last_update_submitted_qc>November 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Jingqing Hu</investigator_full_name>
    <investigator_title>Director of Institute of Basic Theory of Traditional Chinese Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blind Loop Syndrome</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</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/NCT02967718
org study id: 2014CB542903
nct id: NCT02967718
lead sponsor: 
has dmc: Yes
Coronary heart disease is still the major cause of death in China. Chinese medicine plays
      more and more important role in CHD prevention and treatment. Phlegm and blood stasis are its
      major pathological basis. Based on that, the investigator aims to evaluate the evolutionary
      process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section
      observation combining with longitudinal tracking on-site survey method so as to guide the
      clinical treatment of CHD.
Coronary heart disease (CHD) is a major cause of myocardial infarct (MI) and death induced by
      atherosclerosis or coronary artery spasm. Despite improvements in interventional and
      pharmacological therapy for acute MI, the mortality early after AMI remains high. Nowadays,
      as our life quality develops and dietary structure changes, the morbidity of hyperlipidemia
      dramatically increased. Based on the Chinese medicine, hyperlipidemia belongs to phlegm and
      it's the basis of atherosclerosis, blood-stasis is the pathological basis of ischemia.
      Therefore, the investigator proposes that phlegm and blood-stasis syndrome is the main
      differentiation on CHD. Based on that, the investigator prospectively and retrospectively
      explores the evolutionary process of CHD phlegm-blood stasis syndrome by large samples,
      multi-centre, cross-section observation combining with longitudinal tracking on-site survey
      method.It will provide evidence and guidance to the future clinical treatment using Chinese
      medicine.
observational model: Cohort
time perspective: Cross-Sectional
measure: all cause mortality
time frame: 6 months
arm group label: Control group
description: the healthy patients
arm group label: Metabolic syndrome group
description: Include patients who are accordance with diagnostic criteria of metabolic syndrome
arm group label: CHD stable stage group
description: Include patients who are accordance with diagnostic criteria of asymptomatic angina, stable angina or stable (more than 1 month) acute coronary syndrome
arm group label: Acute coronary syndrome group
description: Include patients who are accordance with diagnostic criteria of unstable angina or non-ST-segment elevated myocardial infarction
arm group label: PCI or CABG group
description: Include the patients who will undergo percutaneous coronary intervention of coronary artery bypass grafting
arm group label: CHD heart failure group
description: Include the patients who suffered heart failure cause by CHD
serum sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Weiming Xu, Doctor
phone: 86-15652608470
email: dreameng2008@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: China Academy of Chinese Medical Sciences
investigator full name: Jingqing Hu
investigator title: Director of Institute of Basic Theory of Traditional Chinese Medicine
mesh term: Blind Loop Syndrome
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
sharing ipd: Undecided