<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/NCT04414176</url>
  </required_header>
  <id_info>
    <org_study_id>296055</org_study_id>
    <nct_id>NCT04414176</nct_id>
  </id_info>
  <brief_title>Iran- Premature Coronary Artery Disease</brief_title>
  <acronym>I-PAD</acronym>
  <official_title>Determining the Prevalence of Premature Coronary Heart Disease and it's Risk Factors According to Different Ethnicities and Religions in Iran and Developing a Biobank for Genetic and Epigenetic Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Iran Ministry of Health, Treatment, and Medical Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Isfahan University of Medical Sciences</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 case-control study will be conducted all over the country (in Persian, Kurd, Azari,&#xD;
      Arab, Lor, Bakhtiari, Baluch, Turkman, Qashqai, Gilak and in Muslims, Christians, Jewish, and&#xD;
      Zoroastrian). the investigators intend to recruit patients (men 60≥ years of age and women&#xD;
      70≥ years of age) who underwent coronary angiography. Patients with coronary artery stenosis&#xD;
      more than 75% (or left-main stenosis more than 50%) are defined as case group and patients&#xD;
      with normal angiography are considered as the control group. at the same time, the prevalence&#xD;
      of premature coronary artery disease in patients with positive angiography will be&#xD;
      calculated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary heart disease (CHD) is one of the most important causes of mortality in the world&#xD;
      and accounts for up to 30% of deaths. CHD is also prevalent in Iran and in some studies, the&#xD;
      prevalence of the disease has been reported to be about 20 to 30 percent. The prevalence of&#xD;
      premature coronary heart disease (CHD) is increasing every year, which is related to the risk&#xD;
      factors for cardiovascular disease in humans. The prevalence of premature CHD in Iran is also&#xD;
      high, which justify better understanding of the factors affecting it.&#xD;
&#xD;
      Many known risk factors are involved in coronary artery disease, including age, sex, obesity,&#xD;
      high blood pressure, diabetes, dyslipidemia, smoking and family history. These risk factors&#xD;
      do not have the same prevalence or attributable risk among different ethnicities and&#xD;
      religions. Also due to genetic differences, the effect of environmental factors can&#xD;
      accelerate or diminish the effects of some factors on the occurance of premature CHD. These&#xD;
      mechanisms are often unknown, but high-risk environments can trigger an earlier onset of CHD&#xD;
      in people who are genetically susceptible. This relation is called the genetic-environment&#xD;
      interaction. As showed in previous reports, CHD is a multifactorial disease that can be&#xD;
      affected by environmental factors and expression of different genes.&#xD;
&#xD;
      In this case-control study the investigators intend to recruit documented CHD patients who&#xD;
      underwent coronary angiography from diverse ethnic and religious groups. A total of 5000&#xD;
      individuals from different ethnic backgrounds such as Persian (fars), Turk, Kurd, Arab, Lor,&#xD;
      Bakhtiari, Baluch, Turkman, Qashqai, Gilak and in Muslims, Christians, Jews, and Zoroastrians&#xD;
      will be selected throughout the country. Sampling among different ethnicities and religions&#xD;
      will be based on their proportion of the total population.&#xD;
&#xD;
      Variables such as age, sex, ethnicity, religion, socioeconomic characteristics (educational&#xD;
      level, working status, income), history of smoking, alcohol consumption, addiction, family&#xD;
      and personal history of CHD, psychosocial habit, physical activity, and dietary habits will&#xD;
      be collected. The heart rate and systolic and diastolic blood pressure will be taken twice in&#xD;
      sitting position, and under standard conditions and the average of the two measurements will&#xD;
      be recorded. The patient's weight (in kilograms), and height (in meters), the circumference&#xD;
      of the wrist, neck, thigh, waist, and hip (all in centimeters) will be measured in light&#xD;
      clothes and without shoes and body mass index and waist to hip ratio will be calculated.&#xD;
&#xD;
      Blood samples will be evaluated for fasting blood sugar and lipid profiles (Triglyceride,&#xD;
      High-density lipoprotein-C, Low-density lipoprotein-C, and Total Cholesterol).&#xD;
&#xD;
      Samples of serum, plasma, buffy coat, whole blood, urine, stool, and saliva will be frozen&#xD;
      and Individuals genetic and epigenetic variations will be examined in later stages.&#xD;
&#xD;
      All biological Samples will be transferred to the central lab of the Isfahan Cardiovascular&#xD;
      Research Institute to create a BioBank for future genetic and epigenetic studies. The data&#xD;
      collection teams will receive the necessary training in several sessions and the supervisory&#xD;
      committee will regularly monitor the implementation of the plan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 25, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Odds ratio</measure>
    <time_frame>2018 to 2020</time_frame>
    <description>Odds ratio for life style risk factors among different ethnicities and religions</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Coronary Vessels</condition>
  <arm_group>
    <arm_group_label>Case</arm_group_label>
    <description>Patients with coronary artery stenosis more than 75% (or left-main stenosis more than 50%) are defined as case group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Patients with normal angiography are considered as control group.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be evaluated for fasting blood sugar and lipid profiles. All biological&#xD;
      samples (serum, plasma, buffy coat, whole blood, urine, stool, and saliva) will be&#xD;
      transferred to the central lab of the Isfahan Cardiovascular Research Institute to create a&#xD;
      biobank (-80 c) for future genetic and epigenetic studies.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with documented coronary angiography&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women less than 60 and 70 years respectively&#xD;
&#xD;
          -  Ethnicity&#xD;
&#xD;
          -  Coronary artery stenosis more than 75% (or left-main stenosis more than 50%) or&#xD;
             patients with normal angiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with past medical history of CABG or documented coronary stenosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ehsan Zarepur, MD</last_name>
    <phone>+98 3136115109</phone>
    <email>ehsanzarepur@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nizal Sarrafzadegan, MD</last_name>
    <phone>+98 3136115310</phone>
    <email>nsarrafzadegan@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Isfahan Cardiovascular Research Institute</name>
      <address>
        <city>Isfahan</city>
        <zip>8158388994</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ehsan Zarepur, M.D.</last_name>
      <phone>+983136115109</phone>
      <email>ehsanzarepur@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Ehsan Zarepur</investigator_full_name>
    <investigator_title>Dr. Ehsan Zarepur (Cardiology resident, PhD candidate)</investigator_title>
  </responsible_party>
  <keyword>Premature coronary heart disease</keyword>
  <keyword>Ethnicity</keyword>
  <keyword>Religion</keyword>
  <keyword>Biobank</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT04414176
org study id: 296055
nct id: NCT04414176
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This case-control study will be conducted all over the country (in Persian, Kurd, Azari,
      Arab, Lor, Bakhtiari, Baluch, Turkman, Qashqai, Gilak and in Muslims, Christians, Jewish, and
      Zoroastrian). the investigators intend to recruit patients (men 60≥ years of age and women
      70≥ years of age) who underwent coronary angiography. Patients with coronary artery stenosis
      more than 75% (or left-main stenosis more than 50%) are defined as case group and patients
      with normal angiography are considered as the control group. at the same time, the prevalence
      of premature coronary artery disease in patients with positive angiography will be
      calculated.
Coronary heart disease (CHD) is one of the most important causes of mortality in the world
      and accounts for up to 30% of deaths. CHD is also prevalent in Iran and in some studies, the
      prevalence of the disease has been reported to be about 20 to 30 percent. The prevalence of
      premature coronary heart disease (CHD) is increasing every year, which is related to the risk
      factors for cardiovascular disease in humans. The prevalence of premature CHD in Iran is also
      high, which justify better understanding of the factors affecting it.

      Many known risk factors are involved in coronary artery disease, including age, sex, obesity,
      high blood pressure, diabetes, dyslipidemia, smoking and family history. These risk factors
      do not have the same prevalence or attributable risk among different ethnicities and
      religions. Also due to genetic differences, the effect of environmental factors can
      accelerate or diminish the effects of some factors on the occurance of premature CHD. These
      mechanisms are often unknown, but high-risk environments can trigger an earlier onset of CHD
      in people who are genetically susceptible. This relation is called the genetic-environment
      interaction. As showed in previous reports, CHD is a multifactorial disease that can be
      affected by environmental factors and expression of different genes.

      In this case-control study the investigators intend to recruit documented CHD patients who
      underwent coronary angiography from diverse ethnic and religious groups. A total of 5000
      individuals from different ethnic backgrounds such as Persian (fars), Turk, Kurd, Arab, Lor,
      Bakhtiari, Baluch, Turkman, Qashqai, Gilak and in Muslims, Christians, Jews, and Zoroastrians
      will be selected throughout the country. Sampling among different ethnicities and religions
      will be based on their proportion of the total population.

      Variables such as age, sex, ethnicity, religion, socioeconomic characteristics (educational
      level, working status, income), history of smoking, alcohol consumption, addiction, family
      and personal history of CHD, psychosocial habit, physical activity, and dietary habits will
      be collected. The heart rate and systolic and diastolic blood pressure will be taken twice in
      sitting position, and under standard conditions and the average of the two measurements will
      be recorded. The patient's weight (in kilograms), and height (in meters), the circumference
      of the wrist, neck, thigh, waist, and hip (all in centimeters) will be measured in light
      clothes and without shoes and body mass index and waist to hip ratio will be calculated.

      Blood samples will be evaluated for fasting blood sugar and lipid profiles (Triglyceride,
      High-density lipoprotein-C, Low-density lipoprotein-C, and Total Cholesterol).

      Samples of serum, plasma, buffy coat, whole blood, urine, stool, and saliva will be frozen
      and Individuals genetic and epigenetic variations will be examined in later stages.

      All biological Samples will be transferred to the central lab of the Isfahan Cardiovascular
      Research Institute to create a BioBank for future genetic and epigenetic studies. The data
      collection teams will receive the necessary training in several sessions and the supervisory
      committee will regularly monitor the implementation of the plan.
observational model: Case-Control
time perspective: Prospective
measure: Odds ratio
time frame: 2018 to 2020
description: Odds ratio for life style risk factors among different ethnicities and religions
arm group label: Case
description: Patients with coronary artery stenosis more than 75% (or left-main stenosis more than 50%) are defined as case group
arm group label: Control
description: Patients with normal angiography are considered as control group.
Blood samples will be evaluated for fasting blood sugar and lipid profiles. All biological
      samples (serum, plasma, buffy coat, whole blood, urine, stool, and saliva) will be
      transferred to the central lab of the Isfahan Cardiovascular Research Institute to create a
      biobank (-80 c) for future genetic and epigenetic studies.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 70 Years
healthy volunteers: No
last name: Ehsan Zarepur, MD
phone: +98 3136115109
email: ehsanzarepur@gmail.com
last name: Nizal Sarrafzadegan, MD
phone: +98 3136115310
email: nsarrafzadegan@gmail.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Ehsan Zarepur
investigator title: Dr. Ehsan Zarepur (Cardiology resident, PhD candidate)
mesh term: Premature Birth