<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/NCT04444024</url>
  </required_header>
  <id_info>
    <org_study_id>2020TJUTCM</org_study_id>
    <nct_id>NCT04444024</nct_id>
  </id_info>
  <brief_title>Effect of Hypercholesterolemia With or Without Hypertension on Coronary Artery Stenosis in Patients With Angina: a Retrospective Study</brief_title>
  <official_title>Effect of Hypercholesterolemia Alone or Combined With Hypertension on the Degree of Coronary Artery Stenosis in Patients With Coronary Heart Disease Angina Pectoris: a Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin University of Traditional Chinese Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, retrospective clinical study was carried out in the medical records management&#xD;
      system of 6 hospitals in Tianjin. Patients who were suffered with Coronary heart disease&#xD;
      angina pectoris and underwent coronary angiography are collected. The investigators collect&#xD;
      and analyze the demographics, laboratory information, clinical outcome data, and coronary&#xD;
      angiographic data of patients. To explore the correlation between hypercholesterolemia and&#xD;
      the degree of coronary artery stenosis of Coronary heart disease angina pectoris, and to&#xD;
      further research the influence of hypertension on total cholesterol level and coronary artery&#xD;
      stenosis, and provide guidance for clinical prevention and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on the total cholesterol level, the investigators divided patients into 3 groups:&#xD;
      patients with TC &lt; 5.18 mmol/l belong to normal TC (NTC) group, 5.18 ≤ TC &lt; 6.19 mmol/l is&#xD;
      borderline-high TC (BHTC) group, those with TC ≥6.19 mmol/l belong to high TC (HTC) group,&#xD;
      and the correlation between the TC and the degree of coronary artery stenosis is evaluated.&#xD;
      With or without hypertension will be further stratified to assess the effect of with or&#xD;
      without hypertension on the correlation between TC levels and the degree of coronary artery&#xD;
      stenosis. The 6 subgroups are: NTC/-HTN group, NTC/+HTN group, BHTC/-HTN group, BHTC/+HTN&#xD;
      group, HTC/-HTN group, HTC/+HTN group.&#xD;
&#xD;
      The investigators refer to the recent diagnostic guidelines for coronary heart disease angina&#xD;
      pectoris at home and abroad. The diagnosis can be given if it meets any one or more of the&#xD;
      following:&#xD;
&#xD;
        1. There was a clear history of old myocardial infarction.&#xD;
&#xD;
        2. Previous coronary angiography or coronary CTA examination showed that at least one major&#xD;
           branch of coronary artery has a lumen diameter stenosis ≥50%.&#xD;
&#xD;
        3. Those with ST-segment depression or T-wave inversion on ECG after coronary&#xD;
           revascularization.&#xD;
&#xD;
      The investigators will redefined hypertension as systolic blood pressure ≥130 mmHg or&#xD;
      diastolic blood pressure ≥80 mmHg according to the recently published 2017 ACC/AHA&#xD;
      guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting blood glucose in clinical biochemical tests.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the fasting blood glucose data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycated hemoglobin in clinical biochemical tests.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the glycated hemoglobin data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total cholesterol in clinical biochemical tests.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the total cholesterol data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Triglyceride in clinical biochemical tests.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the triglyceride data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Low density lipoprotein cholesterol in clinical biochemical tests.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the low density lipoprotein cholesterol data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High density lipoprotein cholesterol in clinical biochemical tests.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the high density lipoprotein cholesterol data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C-reactive protein in clinical biochemical tests.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the C-reactive protein data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fibrinogen in clinical biochemical tests.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the fibrinogen data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coronary angiography data in imaging examination.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect coronary angiography data of the patient's hospitalization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Age in demographics.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the age data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender in demographics.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the gender data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ethnicity in demographics.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the ethnicity data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight in demographics.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the weight data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking in demographics.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the smoking data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical history in demographics.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the medical history data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure in demographics.</measure>
    <time_frame>one year</time_frame>
    <description>In the hospital medical record management system, the investigators collect the blood pressure data of the first day of hospitalization of the patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the correlation between total cholesterol level and the degree of coronary artery stenosis</measure>
    <time_frame>one year</time_frame>
    <description>Based on the total cholesterol level, the investigators divide patients into 3 groups. According to the location and degree of the lumen stenosis, the score of the degree of each coronary artery stenosis is calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the effect of with or without hypertension on the correlation between total cholesterol level and the degree of coronary artery stenosis</measure>
    <time_frame>one year</time_frame>
    <description>According to with or without hypertension, the patients are further divided into 6 subgroups.</description>
  </secondary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Atherosclerotic Heart Disease With Angina Nos</condition>
  <arm_group>
    <arm_group_label>NTC/-HTN group</arm_group_label>
    <description>Patients with TC &lt; 5.18 mmol/l, systolic blood pressure &lt;130 mmHg and diastolic blood pressure &lt;80 mmHg belong to normal TC/ none hypertension(NTC/-HTN) group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NTC/+HTN group</arm_group_label>
    <description>Patients with TC &lt; 5.18 mmol/l, systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg belong to normal TC/ hypertension(NTC/+HTN) group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BHTC/-HTN group</arm_group_label>
    <description>Patients whose TC is 5.18 ≤ TC &lt; 6.19 mmol/l, systolic blood pressure &lt;130 mmHg and diastolic blood pressure &lt;80 mmHg belong to borderline-high TC/ none hypertension (BHTC/-HTN) group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BHTC/+HTN group</arm_group_label>
    <description>Patients whose TC is 5.18 ≤ TC &lt; 6.19 mmol/l, systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg belong to borderline-high TC/ hypertension (BHTC/+HTN) group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HTC/-HTN group</arm_group_label>
    <description>Patients with TC ≥6.19 mmol/l, systolic blood pressure &lt;130 mmHg and diastolic blood pressure &lt;80 mmHg belong to high TC/ none hypertension(HTC/-HTN) group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HTC/+HTN group</arm_group_label>
    <description>Patients with TC ≥6.19 mmol/l, systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥ 80 mmHg belong to high TC/ hypertension(HTC/+HTN) group.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The collaborative network of Coronary heart disease research medical units formed by the&#xD;
        research team includes the First affiliated Hospital of Tianjin University of traditional&#xD;
        Chinese Medicine, the Second affiliated Hospital of Tianjin University of traditional&#xD;
        Chinese Medicine, Tianjin Nankai Hospital, the affiliated Hospital of Tianjin Institute of&#xD;
        traditional Chinese Medicine, Tianjin chest Hospital and Tianjin Medical University General&#xD;
        Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged from 35 to 75 years old, male or female.&#xD;
&#xD;
          2. Those who were hospitalized between September 1, 2014 and September 1, 2019.&#xD;
&#xD;
          3. Patients with Coronary heart disease angina pectoris and have undergone coronary&#xD;
             angiography in the inpatient department of cardiovascular internal medicine.&#xD;
&#xD;
          4. The diagnosis of hypercholesterolemia, Coronary heart disease angina pectoris and&#xD;
             hypertension is accorded with the diagnostic criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those with other cardiac diseases, gastroesophageal reflux disease or hiatal hernia,&#xD;
             neurosis, spinal or vertebral artery cervical spondylosis, hyperthyroidism,&#xD;
             climacteric syndrome, etc.&#xD;
&#xD;
          2. Those with myocarditis, cardiomyopathy, acute myocardial infarction, third degree of&#xD;
             heart failure, severe heart valve disease, major diseases such as malignant tumor and&#xD;
             serious metabolic diseases, liver failure or renal failure.&#xD;
&#xD;
          3. Those with psychotic disorders, or cognitive dysfunction.&#xD;
&#xD;
          4. Those of childbearing age and have fertility requirements, or pregnant women or&#xD;
             lactating women.&#xD;
&#xD;
          5. Those allergic to iodine contrast medium.&#xD;
&#xD;
          6. Those who are not suitable for the study, as judged by the researcher.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Chunquan Yu, Dr.</last_name>
    <phone>8622-59596309</phone>
    <email>ycq-4@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tianjin University of Traditional Chinese Medicine</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300193</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Chunquan Yu, Dr.</last_name>
      <phone>8622-59596309</phone>
      <email>ycq-4@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 21, 2020</last_update_submitted>
  <last_update_submitted_qc>June 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tianjin University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Chunquan Yu</investigator_full_name>
    <investigator_title>researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04444024
org study id: 2020TJUTCM
nct id: NCT04444024
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A multicenter, retrospective clinical study was carried out in the medical records management
      system of 6 hospitals in Tianjin. Patients who were suffered with Coronary heart disease
      angina pectoris and underwent coronary angiography are collected. The investigators collect
      and analyze the demographics, laboratory information, clinical outcome data, and coronary
      angiographic data of patients. To explore the correlation between hypercholesterolemia and
      the degree of coronary artery stenosis of Coronary heart disease angina pectoris, and to
      further research the influence of hypertension on total cholesterol level and coronary artery
      stenosis, and provide guidance for clinical prevention and treatment.
Based on the total cholesterol level, the investigators divided patients into 3 groups:
      patients with TC < 5.18 mmol/l belong to normal TC (NTC) group, 5.18 ≤ TC < 6.19 mmol/l is
      borderline-high TC (BHTC) group, those with TC ≥6.19 mmol/l belong to high TC (HTC) group,
      and the correlation between the TC and the degree of coronary artery stenosis is evaluated.
      With or without hypertension will be further stratified to assess the effect of with or
      without hypertension on the correlation between TC levels and the degree of coronary artery
      stenosis. The 6 subgroups are: NTC/-HTN group, NTC/+HTN group, BHTC/-HTN group, BHTC/+HTN
      group, HTC/-HTN group, HTC/+HTN group.

      The investigators refer to the recent diagnostic guidelines for coronary heart disease angina
      pectoris at home and abroad. The diagnosis can be given if it meets any one or more of the
      following:

        1. There was a clear history of old myocardial infarction.

        2. Previous coronary angiography or coronary CTA examination showed that at least one major
           branch of coronary artery has a lumen diameter stenosis ≥50%.

        3. Those with ST-segment depression or T-wave inversion on ECG after coronary
           revascularization.

      The investigators will redefined hypertension as systolic blood pressure ≥130 mmHg or
      diastolic blood pressure ≥80 mmHg according to the recently published 2017 ACC/AHA
      guidelines.
observational model: Case-Only
time perspective: Retrospective
measure: Fasting blood glucose in clinical biochemical tests.
time frame: one year
description: In the hospital medical record management system, the investigators collect the fasting blood glucose data of the first day of hospitalization of the patients.
measure: Glycated hemoglobin in clinical biochemical tests.
time frame: one year
description: In the hospital medical record management system, the investigators collect the glycated hemoglobin data of the first day of hospitalization of the patients.
measure: Total cholesterol in clinical biochemical tests.
time frame: one year
description: In the hospital medical record management system, the investigators collect the total cholesterol data of the first day of hospitalization of the patients.
measure: Triglyceride in clinical biochemical tests.
time frame: one year
description: In the hospital medical record management system, the investigators collect the triglyceride data of the first day of hospitalization of the patients.
measure: Low density lipoprotein cholesterol in clinical biochemical tests.
time frame: one year
description: In the hospital medical record management system, the investigators collect the low density lipoprotein cholesterol data of the first day of hospitalization of the patients.
measure: High density lipoprotein cholesterol in clinical biochemical tests.
time frame: one year
description: In the hospital medical record management system, the investigators collect the high density lipoprotein cholesterol data of the first day of hospitalization of the patients.
measure: C-reactive protein in clinical biochemical tests.
time frame: one year
description: In the hospital medical record management system, the investigators collect the C-reactive protein data of the first day of hospitalization of the patients.
measure: Fibrinogen in clinical biochemical tests.
time frame: one year
description: In the hospital medical record management system, the investigators collect the fibrinogen data of the first day of hospitalization of the patients.
measure: Coronary angiography data in imaging examination.
time frame: one year
description: In the hospital medical record management system, the investigators collect coronary angiography data of the patient's hospitalization.
measure: Age in demographics.
time frame: one year
description: In the hospital medical record management system, the investigators collect the age data of the first day of hospitalization of the patients.
measure: Gender in demographics.
time frame: one year
description: In the hospital medical record management system, the investigators collect the gender data of the first day of hospitalization of the patients.
measure: Ethnicity in demographics.
time frame: one year
description: In the hospital medical record management system, the investigators collect the ethnicity data of the first day of hospitalization of the patients.
measure: Weight in demographics.
time frame: one year
description: In the hospital medical record management system, the investigators collect the weight data of the first day of hospitalization of the patients.
measure: Smoking in demographics.
time frame: one year
description: In the hospital medical record management system, the investigators collect the smoking data of the first day of hospitalization of the patients.
measure: Medical history in demographics.
time frame: one year
description: In the hospital medical record management system, the investigators collect the medical history data of the first day of hospitalization of the patients.
measure: Blood pressure in demographics.
time frame: one year
description: In the hospital medical record management system, the investigators collect the blood pressure data of the first day of hospitalization of the patients.
measure: Evaluate the correlation between total cholesterol level and the degree of coronary artery stenosis
time frame: one year
description: Based on the total cholesterol level, the investigators divide patients into 3 groups. According to the location and degree of the lumen stenosis, the score of the degree of each coronary artery stenosis is calculated.
measure: Assess the effect of with or without hypertension on the correlation between total cholesterol level and the degree of coronary artery stenosis
time frame: one year
description: According to with or without hypertension, the patients are further divided into 6 subgroups.
arm group label: NTC/-HTN group
description: Patients with TC < 5.18 mmol/l, systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg belong to normal TC/ none hypertension(NTC/-HTN) group.
arm group label: NTC/+HTN group
description: Patients with TC < 5.18 mmol/l, systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg belong to normal TC/ hypertension(NTC/+HTN) group.
arm group label: BHTC/-HTN group
description: Patients whose TC is 5.18 ≤ TC < 6.19 mmol/l, systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg belong to borderline-high TC/ none hypertension (BHTC/-HTN) group.
arm group label: BHTC/+HTN group
description: Patients whose TC is 5.18 ≤ TC < 6.19 mmol/l, systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg belong to borderline-high TC/ hypertension (BHTC/+HTN) group.
arm group label: HTC/-HTN group
description: Patients with TC ≥6.19 mmol/l, systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg belong to high TC/ none hypertension(HTC/-HTN) group.
arm group label: HTC/+HTN group
description: Patients with TC ≥6.19 mmol/l, systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥ 80 mmHg belong to high TC/ hypertension(HTC/+HTN) group.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
last name: Chunquan Yu, Dr.
phone: 8622-59596309
email: ycq-4@163.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tianjin University of Traditional Chinese Medicine
investigator full name: Chunquan Yu
investigator title: researcher
mesh term: Hypertension
mesh term: Heart Diseases
mesh term: Angina Pectoris
mesh term: Coronary Stenosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Hypercholesterolemia
sharing ipd: Yes