<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/NCT03040869</url>
  </required_header>
  <id_info>
    <org_study_id>2016-02-25-1</org_study_id>
    <nct_id>NCT03040869</nct_id>
  </id_info>
  <brief_title>Risk Facotors in Young CHD Patients</brief_title>
  <official_title>Risk Factors Investigation in Young Patients With Coronary Artery Disease and Their Clinical Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</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>
      Coronary heart disease (CHD) is the leading global cause of human death. Over the past&#xD;
      decade, level of overall diagnosis and treatment of CHD has been greatly improved due to the&#xD;
      progression of clinical research and development of technical means and the mortality of CHD&#xD;
      has decreased by nearly 50% in western countries [1]. However, there are surveys shows that&#xD;
      with the improvement of living standards and changes in lifestyle, the incidence of CHD is&#xD;
      still rising in China and other developing countries, and the prevalence trend is obvious&#xD;
      younger [2]. The so-called young CHD, generally refers to the age at onset of CHD is less&#xD;
      than or equal to 45 years. Compared with other age-group CHD, young CHD has the following&#xD;
      characteristics: 1. Genetic factors have a stronger effect at younger onset ages, and&#xD;
      incidence with obvious familial aggregation[3]; 2 Often with the onset of acute coronary&#xD;
      syndrome, presumably may be associated with strong inflammation of the lesion; 3. Two&#xD;
      extremes often exists in coronary lesions: mild or no atherosclerosis and severe&#xD;
      triple-vessel disease; 4 Rapid progression of atherosclerotic lesions, stent restenosis in&#xD;
      the same site repeated after interventional treatment, rapid progress of lesion in&#xD;
      non-intervention site;5 Surgical mortality is low in regardless of interventional therapy or&#xD;
      bypass surgery, but the rate of revascularization is significantly higher in following 10&#xD;
      years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study method&#xD;
&#xD;
        -  Recruited the patients meet the inclusion criteria since March 2016, collected the&#xD;
           information of the change of risk factors, angina in pre-operation, mode of onset,&#xD;
           characteristics of coronary artery, morbility of treatment,clinical follow-up; ② Collect&#xD;
           the following information in clinical cases: gender, age, history of hypertension,&#xD;
           history of diabetes, cholesterol level, triglyceride level, sedentary, body index,&#xD;
           family history of CHD, genotype of ALDH2 and MTHFR, history of myocardial infarction,&#xD;
           coronary artery lesions and operation situation; ③ The follow-up was performed through&#xD;
           clinic and telephone every half or one year. The details include whether recurrence of&#xD;
           angina, the main symptom, the cause of attack, lasting time, the efficacy of taking&#xD;
           nitroglycerin, whether performed electrocardiography examination, whether occurred&#xD;
           myocardial infarction and the attack site. whether performed interventional therapy and&#xD;
           CABG surgery again and the cause of surgery, whether re-examined coronary&#xD;
           arteriongraphy, whether death and the cause, and the occurred date in above events; ④&#xD;
           Analysis the pathogenic intensity with each risk factors with other age group CHD.&#xD;
&#xD;
      3.2 Study population 3.2.1 inclusion criteria&#xD;
&#xD;
      Young CHD group:&#xD;
&#xD;
        -  Below or equal to 45 years of age;&#xD;
&#xD;
           ② Patients suffered stable or latent coronary heart disease, unstable angina, non-ST&#xD;
           segment elevation myocardial infarction or ST segment elevation myocardial infarction&#xD;
           diagnosed by coronary angiography or coronary CT scan;&#xD;
&#xD;
           ③ Signed informed consent form. Non-young CHD group&#xD;
&#xD;
        -  Below or equal to 45 years of age;&#xD;
&#xD;
           ② Patients suffered stable or latent coronary heart disease, unstable angina, non-ST&#xD;
           segment elevation myocardial infarction or ST segment elevation myocardial infarction&#xD;
           diagnosed by Coronary angiography or coronary CT scan;&#xD;
&#xD;
           ③ Risk factors such as the gender, high cholesterol, high blood pressure, overweight,&#xD;
           diabetes, smoking, homocysteine levels matched with inclusion criteria 1 subjects&#xD;
           enrolled.&#xD;
&#xD;
           ④ Signed informed consent form Young non-coronary heart disease&#xD;
&#xD;
        -  Below or equal to 45 years of age; ② Patients were confirmed to rule out the stable or&#xD;
           latent coronary heart disease, unstable angina, non-ST segment elevation myocardial&#xD;
           infarction or ST segment elevation myocardial infarction diagnosed by Coronary&#xD;
           angiography or coronary CT scan;&#xD;
&#xD;
           ③ Signed Informed consent form. 3.2.2 Exclusion criteria Exclusion criteria in each&#xD;
           group are as follows&#xD;
&#xD;
        -  Patients who suffered serious liver and kidney diseases, infections, severe systemic&#xD;
           disease such as blood disease and malignant tumor;&#xD;
&#xD;
           ② Pregnancy or breast-feeding women;&#xD;
&#xD;
             -  Patients who could not timely follow up or refuse to participate in this study.&#xD;
                3.2.3 Exit criteria Subjects were claimed to withdraw informed consent. 3.3&#xD;
                Grouping method and cases number&#xD;
&#xD;
        -  Experimental group：1250 samples&#xD;
&#xD;
             -  Positive control group：1250 samples ③ Negative control group：500 samples&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2020</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>3 Months</target_duration>
  <primary_outcome>
    <measure>heart failure</measure>
    <time_frame>12 months</time_frame>
    <description>LVEF less than 40%</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Risk Factor, Cardiovascular, Young CHD Patients</condition>
  <arm_group>
    <arm_group_label>CHD Patients</arm_group_label>
    <description>coronary angioplasty confirmed coronary heart disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-CHD patients</arm_group_label>
    <description>coronary angioplasty confirmed no coronary heart disease.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        ①Below or equal to 45 years of age;&#xD;
&#xD;
        ②Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment&#xD;
        elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by&#xD;
        coronary angiography or coronary CT scan;&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:①Below or equal to 45 years of age;&#xD;
&#xD;
        ②Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment&#xD;
        elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by&#xD;
        coronary angiography or coronary CT scan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who suffered serious liver and kidney diseases, infections, severe systemic&#xD;
             disease such as blood disease and malignant tumor; ②Pregnancy or breast-feeding women;&#xD;
             ③Patients who could not timely follow up or refuse to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
    <investigator_full_name>Xu Lei</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>laboratory test</ipd_description>
  </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/NCT03040869
org study id: 2016-02-25-1
nct id: NCT03040869
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Coronary heart disease (CHD) is the leading global cause of human death. Over the past
      decade, level of overall diagnosis and treatment of CHD has been greatly improved due to the
      progression of clinical research and development of technical means and the mortality of CHD
      has decreased by nearly 50% in western countries [1]. However, there are surveys shows that
      with the improvement of living standards and changes in lifestyle, the incidence of CHD is
      still rising in China and other developing countries, and the prevalence trend is obvious
      younger [2]. The so-called young CHD, generally refers to the age at onset of CHD is less
      than or equal to 45 years. Compared with other age-group CHD, young CHD has the following
      characteristics: 1. Genetic factors have a stronger effect at younger onset ages, and
      incidence with obvious familial aggregation[3]; 2 Often with the onset of acute coronary
      syndrome, presumably may be associated with strong inflammation of the lesion; 3. Two
      extremes often exists in coronary lesions: mild or no atherosclerosis and severe
      triple-vessel disease; 4 Rapid progression of atherosclerotic lesions, stent restenosis in
      the same site repeated after interventional treatment, rapid progress of lesion in
      non-intervention site;5 Surgical mortality is low in regardless of interventional therapy or
      bypass surgery, but the rate of revascularization is significantly higher in following 10
      years.
Study method

        -  Recruited the patients meet the inclusion criteria since March 2016, collected the
           information of the change of risk factors, angina in pre-operation, mode of onset,
           characteristics of coronary artery, morbility of treatment,clinical follow-up; ② Collect
           the following information in clinical cases: gender, age, history of hypertension,
           history of diabetes, cholesterol level, triglyceride level, sedentary, body index,
           family history of CHD, genotype of ALDH2 and MTHFR, history of myocardial infarction,
           coronary artery lesions and operation situation; ③ The follow-up was performed through
           clinic and telephone every half or one year. The details include whether recurrence of
           angina, the main symptom, the cause of attack, lasting time, the efficacy of taking
           nitroglycerin, whether performed electrocardiography examination, whether occurred
           myocardial infarction and the attack site. whether performed interventional therapy and
           CABG surgery again and the cause of surgery, whether re-examined coronary
           arteriongraphy, whether death and the cause, and the occurred date in above events; ④
           Analysis the pathogenic intensity with each risk factors with other age group CHD.

      3.2 Study population 3.2.1 inclusion criteria

      Young CHD group:

        -  Below or equal to 45 years of age;

           ② Patients suffered stable or latent coronary heart disease, unstable angina, non-ST
           segment elevation myocardial infarction or ST segment elevation myocardial infarction
           diagnosed by coronary angiography or coronary CT scan;

           ③ Signed informed consent form. Non-young CHD group

        -  Below or equal to 45 years of age;

           ② Patients suffered stable or latent coronary heart disease, unstable angina, non-ST
           segment elevation myocardial infarction or ST segment elevation myocardial infarction
           diagnosed by Coronary angiography or coronary CT scan;

           ③ Risk factors such as the gender, high cholesterol, high blood pressure, overweight,
           diabetes, smoking, homocysteine levels matched with inclusion criteria 1 subjects
           enrolled.

           ④ Signed informed consent form Young non-coronary heart disease

        -  Below or equal to 45 years of age; ② Patients were confirmed to rule out the stable or
           latent coronary heart disease, unstable angina, non-ST segment elevation myocardial
           infarction or ST segment elevation myocardial infarction diagnosed by Coronary
           angiography or coronary CT scan;

           ③ Signed Informed consent form. 3.2.2 Exclusion criteria Exclusion criteria in each
           group are as follows

        -  Patients who suffered serious liver and kidney diseases, infections, severe systemic
           disease such as blood disease and malignant tumor;

           ② Pregnancy or breast-feeding women;

             -  Patients who could not timely follow up or refuse to participate in this study.
                3.2.3 Exit criteria Subjects were claimed to withdraw informed consent. 3.3
                Grouping method and cases number

        -  Experimental group：1250 samples

             -  Positive control group：1250 samples ③ Negative control group：500 samples
observational model: Cohort
time perspective: Prospective
measure: heart failure
time frame: 12 months
description: LVEF less than 40%
arm group label: CHD Patients
description: coronary angioplasty confirmed coronary heart disease.
arm group label: non-CHD patients
description: coronary angioplasty confirmed no coronary heart disease.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Xu Lei
investigator title: Doctor
sharing ipd: Undecided
ipd description: laboratory test