<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/NCT03016910</url>
  </required_header>
  <id_info>
    <org_study_id>CD20150029</org_study_id>
    <nct_id>NCT03016910</nct_id>
  </id_info>
  <brief_title>Coronary Artery Plaque Burden and Morphology in Type 2 Diabetes Mellitus.</brief_title>
  <acronym>CARPEDIEM</acronym>
  <official_title>Coronary Artery Plaque Burden in Type 2 Diabetes Mellitus. Changes Over Time, Relation to Risk Profile, and Comparison to Acute Myocardial Infarction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Svendborg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Svendborg Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a&#xD;
      morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign&#xD;
      (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the&#xD;
      influence of microvascular dysfunction and additional risk factors on plaque morphology and&#xD;
      plaque burden in patients with diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary artery disease (CAD) is the leading cause of death and morbidity in type 2 diabetes&#xD;
      mellitus (T2DM) and diabetics holds the same risk for death or myocardial infarction (MI) as&#xD;
      patients with a prior (MI) without diabetes. In addition to macrovascular complications, and&#xD;
      traditional cardiac risk factors, T2DM is burdened by microvascular dysfunction affecting&#xD;
      several organs. The dynamics between microvascular dysfunction, known cardiac risk factors&#xD;
      and coronary atherosclerosis in diabetic disease is not well characterized.&#xD;
&#xD;
      In the present study, a primary cohort of 300 type 2 diabetics and a subgroup of 50-100 type&#xD;
      1 diabetics will be examined with CCTA at baseline and after one year. In addition, CAD in&#xD;
      diabetes will be compared to a historical cohort of patients with acute myocardial infarction&#xD;
      (AMI).&#xD;
&#xD;
      All study participant will undergo the following examinations at baseline:&#xD;
&#xD;
        -  CCTA&#xD;
&#xD;
        -  CAC-score&#xD;
&#xD;
        -  Transthoracic echocardiography&#xD;
&#xD;
        -  12-lead ECG&#xD;
&#xD;
        -  Blood pressure and pulse frequency&#xD;
&#xD;
        -  Height, weight, waist to hip-ratio&#xD;
&#xD;
        -  Blood samples and urin samples&#xD;
&#xD;
        -  Medical history&#xD;
&#xD;
      After 12 months all of the above examinations will be repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in plaque burden stratified by diabetic complications.</measure>
    <time_frame>Baseline,12 months.</time_frame>
    <description>Changes in plaque burden (percentage) during 12 months in diabetics with or without diabetic complications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in plaque burden stratified by cardiovascular risk factors</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Changes in plaque burden during 12 months stratified by cardiovascular risk factors (hypertension,hypercholersterolemia, smoking, overweight/obesity)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in plaque morphology stratified by diabetic complications</measure>
    <time_frame>Baseline, 12 months</time_frame>
    <description>Changes in plaque morphology (PR, LAP, NRS, SC) during 12 months in diabetics either with or without diabetic complications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in plaque morphology stratified by cardiovascular risk factors.</measure>
    <time_frame>Baseline,12 months</time_frame>
    <description>Changes in plaque burden during 12-months stratified by cardiovascular risk factors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in plaque burden in diabetes compared to AMI-patients without diabetes.</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>A comparison of plaque burden (percentage) in diabetes and a historical cohort of AMI-patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plaque morphology in diabetes compared to AMI-patients without diabetes.</measure>
    <time_frame>Baseline,12-months</time_frame>
    <description>A comparison of plaque morphology in diabetes and a historical cohort of AMI-patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plaque burden during 12 months in relation to HbA1c and cholesterol levels.</measure>
    <time_frame>Baseline,12-months</time_frame>
    <description>Changes in plaque burden during 12 months stratified by historical levels of cholesterol and HbA1c levels recorded from onset of diabetes to present.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plaque morphology during 12 months in relation to HbA1c and cholesterol levels.</measure>
    <time_frame>Baseline,12-months</time_frame>
    <description>Changes in plaque morphology during 12 months stratified by historical levels of cholesterol and HbA1c levels recorded once a year from onset of diabetes to present.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of asymtomatic CAD in diabetes on future events.</measure>
    <time_frame>5-7 years</time_frame>
    <description>Long term follow-up to evaluate the impact of asymptomatic CAD (plaque burden and morphology) in diabetes on death, coronary heart attack, hospitalization due to unstable angina, heart failure and ischemic stroke.&#xD;
Clinical outcomes will be recorded from journal records and analyzed after 5-7 years.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Type2 Diabetes</condition>
  <condition>Atherosclerosis</condition>
  <condition>Plaque, Atherosclerotic</condition>
  <condition>Plaque Vulnerability</condition>
  <condition>Diabetes Complications</condition>
  <condition>Microalbuminuria</condition>
  <condition>Coronary Computed Tomography Angiography</condition>
  <arm_group>
    <arm_group_label>Type 2 diabetes</arm_group_label>
    <description>This group will consist of 300 patients with type 2 diabetes mellitus without symptoms or known coronary heart disease. The group will be followed for one year and CCTA will be performed at baseline and after one year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 1 diabetes</arm_group_label>
    <description>This group will consist of 50-100 patients with type 1 diabetes mellitus without symptoms or known coronary heart disease. The group will be followed for one year. CCTA will be performed at baseline and after one year.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be stored at -80 degrees celcius for a biobank. These includes:&#xD;
&#xD;
      5 x 2 ml (serum).&#xD;
&#xD;
      4 x 2 ml (ethylenediaminetetraacetic acid &quot;EDTA&quot;).&#xD;
&#xD;
      2 x 2 ml (sodium citrate)&#xD;
&#xD;
      1 x 2 ml (buffy coat)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with type 1 or 2 diabetes mellitus without history of CAD or relevant symptoms&#xD;
        (angina). Patients are recruited at the out-patient clinic at Svendborg Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Type 1 or 2 diabetes mellitus&#xD;
&#xD;
          -  Ability to provide informed conscent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of CAD&#xD;
&#xD;
          -  Symtoms of CAD (angina)&#xD;
&#xD;
          -  Any tachyarrhythmias making CCTA impossible&#xD;
&#xD;
          -  Glumerular filtration rate (GFR)&lt; 45 ml/min&#xD;
&#xD;
          -  Allergy to iodine contrast&#xD;
&#xD;
          -  Critical illness with life expectancy less than 1 year&#xD;
&#xD;
          -  Documented heart failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth Egstrup, Prof. DMSci</last_name>
    <role>Study Director</role>
    <affiliation>Head of Reseach, Cardiovascular Research Unit, OUH Svendborg Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurits J Heinsen, MD</last_name>
    <phone>+4563202429</phone>
    <email>lauritsheinsen@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kenneth Egstrup, Prof. DMSci</last_name>
    <phone>+4563202402</phone>
    <email>kenneth.egstrup@rsyd.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital of Odense (OUH) Svendborg Hospital</name>
      <address>
        <city>Svendborg</city>
        <state>Fyn</state>
        <zip>5700</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurits J Heinsen, MD</last_name>
      <phone>+4563202429</phone>
      <email>lauritsheinsen@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>kenneth Egstrup, Prof. DMSci</last_name>
      <phone>+4563202402</phone>
      <email>kenneth.egstrup@rsyd.dk</email>
    </contact_backup>
    <investigator>
      <last_name>Laurits J Heinsen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 8, 2017</last_update_submitted>
  <last_update_submitted_qc>January 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Svendborg Hospital</investigator_affiliation>
    <investigator_full_name>Laurits Heinsen</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Diabetes Complications</mesh_term>
    <mesh_term>Plaque, Atherosclerotic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03016910
org study id: CD20150029
nct id: NCT03016910
lead sponsor: 
has dmc: No
Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a
      morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign
      (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the
      influence of microvascular dysfunction and additional risk factors on plaque morphology and
      plaque burden in patients with diabetes mellitus.
Coronary artery disease (CAD) is the leading cause of death and morbidity in type 2 diabetes
      mellitus (T2DM) and diabetics holds the same risk for death or myocardial infarction (MI) as
      patients with a prior (MI) without diabetes. In addition to macrovascular complications, and
      traditional cardiac risk factors, T2DM is burdened by microvascular dysfunction affecting
      several organs. The dynamics between microvascular dysfunction, known cardiac risk factors
      and coronary atherosclerosis in diabetic disease is not well characterized.

      In the present study, a primary cohort of 300 type 2 diabetics and a subgroup of 50-100 type
      1 diabetics will be examined with CCTA at baseline and after one year. In addition, CAD in
      diabetes will be compared to a historical cohort of patients with acute myocardial infarction
      (AMI).

      All study participant will undergo the following examinations at baseline:

        -  CCTA

        -  CAC-score

        -  Transthoracic echocardiography

        -  12-lead ECG

        -  Blood pressure and pulse frequency

        -  Height, weight, waist to hip-ratio

        -  Blood samples and urin samples

        -  Medical history

      After 12 months all of the above examinations will be repeated.
observational model: Cohort
time perspective: Prospective
measure: Changes in plaque burden stratified by diabetic complications.
time frame: Baseline,12 months.
description: Changes in plaque burden (percentage) during 12 months in diabetics with or without diabetic complications.
measure: Changes in plaque burden stratified by cardiovascular risk factors
time frame: Baseline, 12 months
description: Changes in plaque burden during 12 months stratified by cardiovascular risk factors (hypertension,hypercholersterolemia, smoking, overweight/obesity)
measure: Changes in plaque morphology stratified by diabetic complications
time frame: Baseline, 12 months
description: Changes in plaque morphology (PR, LAP, NRS, SC) during 12 months in diabetics either with or without diabetic complications.
measure: Changes in plaque morphology stratified by cardiovascular risk factors.
time frame: Baseline,12 months
description: Changes in plaque burden during 12-months stratified by cardiovascular risk factors
measure: Changes in plaque burden in diabetes compared to AMI-patients without diabetes.
time frame: Baseline and 12 months
description: A comparison of plaque burden (percentage) in diabetes and a historical cohort of AMI-patients.
measure: Changes in plaque morphology in diabetes compared to AMI-patients without diabetes.
time frame: Baseline,12-months
description: A comparison of plaque morphology in diabetes and a historical cohort of AMI-patients.
measure: Changes in plaque burden during 12 months in relation to HbA1c and cholesterol levels.
time frame: Baseline,12-months
description: Changes in plaque burden during 12 months stratified by historical levels of cholesterol and HbA1c levels recorded from onset of diabetes to present.
measure: Changes in plaque morphology during 12 months in relation to HbA1c and cholesterol levels.
time frame: Baseline,12-months
description: Changes in plaque morphology during 12 months stratified by historical levels of cholesterol and HbA1c levels recorded once a year from onset of diabetes to present.
measure: Impact of asymtomatic CAD in diabetes on future events.
time frame: 5-7 years
description: Long term follow-up to evaluate the impact of asymptomatic CAD (plaque burden and morphology) in diabetes on death, coronary heart attack, hospitalization due to unstable angina, heart failure and ischemic stroke.
Clinical outcomes will be recorded from journal records and analyzed after 5-7 years.
arm group label: Type 2 diabetes
description: This group will consist of 300 patients with type 2 diabetes mellitus without symptoms or known coronary heart disease. The group will be followed for one year and CCTA will be performed at baseline and after one year.
arm group label: Type 1 diabetes
description: This group will consist of 50-100 patients with type 1 diabetes mellitus without symptoms or known coronary heart disease. The group will be followed for one year. CCTA will be performed at baseline and after one year.
Blood samples will be stored at -80 degrees celcius for a biobank. These includes:

      5 x 2 ml (serum).

      4 x 2 ml (ethylenediaminetetraacetic acid "EDTA").

      2 x 2 ml (sodium citrate)

      1 x 2 ml (buffy coat)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kenneth Egstrup, Prof. DMSci
role: Study Director
affiliation: Head of Reseach, Cardiovascular Research Unit, OUH Svendborg Hospital
last name: Laurits J Heinsen, MD
phone: +4563202429
email: lauritsheinsen@gmail.com
last name: Kenneth Egstrup, Prof. DMSci
phone: +4563202402
email: kenneth.egstrup@rsyd.dk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Svendborg Hospital
investigator full name: Laurits Heinsen
investigator title: Medical doctor
mesh term: Atherosclerosis
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Complications
mesh term: Plaque, Atherosclerotic
sharing ipd: No