<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/NCT03018769</url>
  </required_header>
  <id_info>
    <org_study_id>FirstTeachingHTianjinUTCM</org_study_id>
    <nct_id>NCT03018769</nct_id>
  </id_info>
  <brief_title>Syndrome Differentiation in the Management of Chronic Stable Coronary Artery Disease (SCAD) to Improve Quality</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</source>
  <brief_summary>
    <textblock>
      1.1 To build a TCM diagnosis and treatment database for chronic stable CAD; 1.2 To summarize&#xD;
      the pattern of TCM medicine used and the effect of the medication in chronic stable CAD.&#xD;
&#xD;
      1.3 To formulate a syndrome differentiation determined medicine plan based on the improvement&#xD;
      in the quality of life on chronic stable CAD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic stable coronary artery disease (SCAD) is a general term for all kinds of coronary&#xD;
      artery disease (CAD) which includes patients with chronic stable angina, oldmyocardial&#xD;
      infarctions and also stable condition after revascularization (i.e percutaneous coronary&#xD;
      intervention （PCI）, coronary artery bypass graft （CABG）). According to 2012 American Heart&#xD;
      Association/American College of Cardiology (AHA/ACC) guide, the objective of the treatment&#xD;
      for SCAD is to maintain or recover patients' exercise tolerance, quality of life and avoid&#xD;
      complication like heart failure，so as to decrease mortality, eliminate symptoms and avoid&#xD;
      adverse reactions.&#xD;
&#xD;
      Traditional Chinese medicine (TCM) has two thousand years of history in managing CAD and has&#xD;
      its advantages in improving quality of life. Using scientific method to evaluate, demonstrate&#xD;
      and conclude the clinical curative effect of TCM is an extremely important task for both TCM&#xD;
      and Chinese and western integrative medicine win the treatment of CAD. Recent researches&#xD;
      mainly focus on certain types or some certain pathological and physiological stages of CAD,&#xD;
      worse still, different areas experts have their own experiences and opinions with the&#xD;
      treatment. There is a lack of unified syndrome differentiation and prescriptions plan for the&#xD;
      chronic stable CAD and not enough attention has been paid to TCM despite it having many&#xD;
      advantages in improving quality of life in these patients. Considering all the above, this&#xD;
      research studied past syndromes research results and real clinical effective chronic SCAD&#xD;
      cases. Cases were analysed and explored, effective cases were filtered, syndrome&#xD;
      differentiation of the prescriptions was refined, thus build a TCM diagnosis and treatment&#xD;
      information database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EuroQol-5 Dimensions (EQ-5D)</measure>
    <time_frame>change from take chinese herb in one week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Four diagnostic method of TCM</measure>
    <time_frame>change from take chinese herb in one week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>electrocardiograms(ECG)</measure>
    <time_frame>change from take chinese herb in one week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>dynamic electrocardiogram</measure>
    <time_frame>change from take chinese herb in one week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ultrasonic cardiogram</measure>
    <time_frame>change from take chinese herb in one week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>treadmill exercise testing (TET)</measure>
    <time_frame>change from take chinese herb in one week</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Chronic Stable Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>chronic SCAD</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chinese Herb</intervention_name>
    <arm_group_label>chronic SCAD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        chronic stable Coronary Artery Disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  without age limit&#xD;
&#xD;
          -  diagnose as chronic SCAD at first visit&#xD;
&#xD;
          -  heart function classification between II~III Canada classification(CCS)&#xD;
&#xD;
          -  Be willing to accept Chinese herbal decoction&#xD;
&#xD;
          -  sign an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suffer from acute myocardial infarction (AMI) ,unstable angina or prior&#xD;
             revascularization(i.e PCI,CABG) in the latest 60 days .&#xD;
&#xD;
          -  have such diseases as follow: a.poorly controlled blood pressure even taken&#xD;
             medicine(systolic pressure≥180mmHg, diastolic pressure≥100mmHg); - severe&#xD;
             arrhythmia(atrial fibrillation with rapid ventricular response, atrial flutter,&#xD;
             paroxysmal ventricular tachycardia, etc); c.pulmonary heart disease, rheumatic heart&#xD;
             disease, myocarditis, cardiomyopathy, aortic dissection, pulmonary embolism.&#xD;
&#xD;
          -  hyperthyreosis, cervical spondylosis, gallbladder-cardiac syndrome, gastroesophageal&#xD;
             reflux, esophageal hiatal hernia, neurosis, climacteric syndrome and other diseases&#xD;
             which would cause chest pain.&#xD;
&#xD;
          -  alanine transaminase(ALT) or serum creatinine(Scr) more than twice the normal&#xD;
             reference value.&#xD;
&#xD;
          -  hemoglobin(Hb)&lt;100g/L or have severe hematological system disease.&#xD;
&#xD;
          -  malignant tumor.&#xD;
&#xD;
          -  pregnant, lactating women or other women have reproductive requirement.&#xD;
&#xD;
          -  psychosis or cognition impairment person.&#xD;
&#xD;
          -  taken chinese medicine decoction in recent two weeks.&#xD;
&#xD;
          -  not take part in any other clinical trail.&#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_contact>
    <last_name>bi mr yingfei, doctor</last_name>
    <phone>022-27432327</phone>
    <email>yingfei1981@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>jingyuan mr mao, doctor</last_name>
    <phone>022-27432327</phone>
    <email>jymao@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine</name>
      <address>
        <city>Anhui</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beijing Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dongfang Hospital of Beijing University of Chinese Medicine</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>the third Affiliated to Beijing University of Chinese Medicine</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Xiyuan Hospital of China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Changchun University of Traditional Chinese Medicine</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Gansu University of Chinese Medicine</name>
      <address>
        <city>Gansu</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial Hospital of Chinese Medicine</name>
      <address>
        <city>Guangdong</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Guangdong Second Troditional Chinese Medicine Hospital</name>
      <address>
        <city>Guangdong</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Heilongjiang Provincial Hospital of traditional Chinese Medicine</name>
      <address>
        <city>Heilongjiang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Henan Province Hospital of TCM</name>
      <address>
        <city>Henan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Henan University of TCM</name>
      <address>
        <city>Henan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Hunan Academy of Chinese Medicine</name>
      <address>
        <city>Hunan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Hunan University of Chinese Medicine</name>
      <address>
        <city>Hunan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Traditional hospital of Hunan University of Traditional Chinese Medicine</name>
      <address>
        <city>Hunan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital of TCM</name>
      <address>
        <city>Jiangsu</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jiangxi Provincial Hospital of Chinese Medicine</name>
      <address>
        <city>Jiangxi</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Liaoning University of Traditional Chinese Medicine</name>
      <address>
        <city>Liaoning</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Liaoning University of traditional Chinese Medicine</name>
      <address>
        <city>Liaoning</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shandong Province Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Shandong</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shanxi Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Shanxi</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shanxi Province Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Shanxi</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital to Shanxi University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanxi</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Shanxi University of Traditional Chinese Medcine</name>
      <address>
        <city>Shanxi</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shijiazhuang Traditional Chinese Medicine Hospita</name>
      <address>
        <city>Shijiazhuang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First Teaching Hospital of Tianjin University of TCM</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Tianjin University of TCM</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region</name>
      <address>
        <city>Xinjiang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 7, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Bi Yingfei</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </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 Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT03018769
org study id: FirstTeachingHTianjinUTCM
nct id: NCT03018769
lead sponsor: 
1.1 To build a TCM diagnosis and treatment database for chronic stable CAD; 1.2 To summarize
      the pattern of TCM medicine used and the effect of the medication in chronic stable CAD.

      1.3 To formulate a syndrome differentiation determined medicine plan based on the improvement
      in the quality of life on chronic stable CAD patients.
Chronic stable coronary artery disease (SCAD) is a general term for all kinds of coronary
      artery disease (CAD) which includes patients with chronic stable angina, oldmyocardial
      infarctions and also stable condition after revascularization (i.e percutaneous coronary
      intervention （PCI）, coronary artery bypass graft （CABG）). According to 2012 American Heart
      Association/American College of Cardiology (AHA/ACC) guide, the objective of the treatment
      for SCAD is to maintain or recover patients' exercise tolerance, quality of life and avoid
      complication like heart failure，so as to decrease mortality, eliminate symptoms and avoid
      adverse reactions.

      Traditional Chinese medicine (TCM) has two thousand years of history in managing CAD and has
      its advantages in improving quality of life. Using scientific method to evaluate, demonstrate
      and conclude the clinical curative effect of TCM is an extremely important task for both TCM
      and Chinese and western integrative medicine win the treatment of CAD. Recent researches
      mainly focus on certain types or some certain pathological and physiological stages of CAD,
      worse still, different areas experts have their own experiences and opinions with the
      treatment. There is a lack of unified syndrome differentiation and prescriptions plan for the
      chronic stable CAD and not enough attention has been paid to TCM despite it having many
      advantages in improving quality of life in these patients. Considering all the above, this
      research studied past syndromes research results and real clinical effective chronic SCAD
      cases. Cases were analysed and explored, effective cases were filtered, syndrome
      differentiation of the prescriptions was refined, thus build a TCM diagnosis and treatment
      information database.
time perspective: Prospective
measure: EuroQol-5 Dimensions (EQ-5D)
time frame: change from take chinese herb in one week
measure: Four diagnostic method of TCM
time frame: change from take chinese herb in one week
measure: electrocardiograms(ECG)
time frame: change from take chinese herb in one week
measure: dynamic electrocardiogram
time frame: change from take chinese herb in one week
measure: ultrasonic cardiogram
time frame: change from take chinese herb in one week
measure: treadmill exercise testing (TET)
time frame: change from take chinese herb in one week
arm group label: chronic SCAD
intervention type: Drug
intervention name: Chinese Herb
arm group label: chronic SCAD
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: bi mr yingfei, doctor
phone: 022-27432327
email: yingfei1981@163.com
last name: jingyuan mr mao, doctor
phone: 022-27432327
email: jymao@126.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: China
responsible party type: Principal Investigator
investigator affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
investigator full name: Bi Yingfei
investigator title: doctor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease