<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/NCT01671930</url>
  </required_header>
  <id_info>
    <org_study_id>MEC 08-4-057</org_study_id>
    <nct_id>NCT01671930</nct_id>
  </id_info>
  <brief_title>Maastricht Biomarker CT Study</brief_title>
  <official_title>Maastricht Biomarker CT Study. Relation Between Cardiovascular Biomarkers and Coronary Atherosclerosis in Patients Undergoing Multi Detector Cardiac Computed Tomography.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction&#xD;
&#xD;
      Cardiovascular disease is the leading cause of death in the Western world. The main cause for&#xD;
      cardiovascular events is the development of atherosclerosis in the coronary arteries. In more&#xD;
      than 70% of cases, myocardial infarctions are caused by atherosclerotic plaque rupture, which&#xD;
      results in subsequent formation of an occluding thrombus. Plaques that have a high risk of&#xD;
      rupture are called vulnerable plaques. Cardiovascular imaging provides a complementary&#xD;
      diagnostic approach in the assessment of cardiovascular risk in patients. However, the lack&#xD;
      of biological detection possibilities of current imaging technologies limits their predictive&#xD;
      value. For instance, multi detector computed tomography (MDCT) is an excellent tool to&#xD;
      visualize coronary atherosclerosis. However, individual risk assessment is still problematic.&#xD;
      Which of the diagnosed atherosclerotic plaques will undergo plaque rupture and lead to acute&#xD;
      vascular events is currently hard to predict. Potentially, serum biomarkers could help&#xD;
      identify the patient at risk. A wide variety of prognostic markers related to atherosclerosis&#xD;
      have been identified in the past to predict for cardiovascular events. Nevertheless, their&#xD;
      predictive value in individual patients is still limited. A difficulty in serum biomarker&#xD;
      research is the requirement of large patient cohorts to study the relation between event rate&#xD;
      and serum biomarker levels. The necessity to perform lengthy and costly studies, hinders the&#xD;
      translation of novel cardiovascular serum biomarkers into the clinic. An alternative approach&#xD;
      could be to study the correlation between levels of serum biomarkers and the presence of&#xD;
      atherosclerosis in the coronary arteries.&#xD;
&#xD;
      Study objectives&#xD;
&#xD;
      Primary objective of the present analysis is to investigate the predictive value of a variety&#xD;
      of serum biomarkers to predict atherosclerosis in the coronary tree of patients undergoing&#xD;
      cardiac MDCT.&#xD;
&#xD;
      Design and Methods&#xD;
&#xD;
      Patients undergoing cardiac MDCT are eligible for the study. Excluded are patients with acute&#xD;
      coronary syndrome, hemodynamic instability, pregnancy, severe renal insufficiency, allergy&#xD;
      for contrast medium and inability to obtain informed consent. Permission to store the serum&#xD;
      samples for future analysis of new prognostic markers for cardiovascular events will be&#xD;
      acquired from the patients. Written information is send to the patient at least 1 week prior&#xD;
      to CT. The samples will be stored coded, at the Biobank Maastricht, for a maximum duration of&#xD;
      15 years. Once measurements from the samples will be performed, the serum samples will be&#xD;
      sent by the Biobank coded to the analyzing researchers, which have no access to the key file&#xD;
      where codes are linked to the specific hospital identity number. This file will be stored by&#xD;
      an independent researcher at the Cardiology department of the Maastricht University Medical&#xD;
      Center. The assessment of atherosclerotic burden of the coronary tree will be performed by&#xD;
      cardiac MDCT specialists blinded to the clinical data and serum biomarker outcome. Biomarker&#xD;
      levels are correlated to the severity and amount of coronary artery disease as assessed by&#xD;
      cardiac MDCT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2007</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>coronary artery disease</measure>
    <time_frame>1 year</time_frame>
    <description>The presence of any coronary atherosclerotic plaque as visible on cardiac CT.&#xD;
The presence of any significant (≥50% luminal stenosis) coronary plaque in the coronary tree.&#xD;
The number of atherosclerotic plaques in the coronary tree.&#xD;
The calcium score (Agatston method).&#xD;
Plaques are categorized as calcified (exclusively content with density &gt;130 Hounsfield units), non-calcified (exclusively content with density &lt;130 Hounsfield units), or mixed (characteristics of both calcified and non-calcified plaque).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5000</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Stenosis</condition>
  <arm_group>
    <arm_group_label>cardiac computed tomographic angiography</arm_group_label>
    <description>Patients refered for cardiac computed tomographic angiography by a cardiologist.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that were refered to undergo cardiac computed tomography by their cardiologist, to&#xD;
        exclude coronary artery disease. Location: tertiary academic hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients refered to cardiac computed tomography to exclude coronary artery disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  severe renal insufficiency&#xD;
&#xD;
          -  severe allergy to contrast medium&#xD;
&#xD;
          -  Inability to obtain informed consent&#xD;
&#xD;
          -  Age below 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>H Crijns, M.D. P.h.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>B Kietselaer, M.D. P.h.D.</last_name>
    <role>Study Director</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>L Hofstra, M.D. P.h.D</last_name>
    <role>Study Chair</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <zip>6202 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Mingels AM, Joosen IA, Versteylen MO, Laufer EM, Winkens MH, Wildberger JE, Van Dieijen-Visser MP, Hofstra L. High-sensitivity cardiac troponin T: risk stratification tool in patients with symptoms of chest discomfort. PLoS One. 2012;7(4):e35059. doi: 10.1371/journal.pone.0035059. Epub 2012 Apr 25.</citation>
    <PMID>22558116</PMID>
  </reference>
  <results_reference>
    <citation>Laufer EM, Mingels AM, Winkens MH, Joosen IA, Schellings MW, Leiner T, Wildberger JE, Narula J, Van Dieijen-Visser MP, Hofstra L. The extent of coronary atherosclerosis is associated with increasing circulating levels of high sensitive cardiac troponin T. Arterioscler Thromb Vasc Biol. 2010 Jun;30(6):1269-75. doi: 10.1161/ATVBAHA.109.200394. Epub 2010 Mar 18.</citation>
    <PMID>20299689</PMID>
  </results_reference>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>May 26, 2014</last_update_submitted>
  <last_update_submitted_qc>May 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Stenosis</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/NCT01671930
org study id: MEC 08-4-057
nct id: NCT01671930
lead sponsor: 
has dmc: No
Introduction

      Cardiovascular disease is the leading cause of death in the Western world. The main cause for
      cardiovascular events is the development of atherosclerosis in the coronary arteries. In more
      than 70% of cases, myocardial infarctions are caused by atherosclerotic plaque rupture, which
      results in subsequent formation of an occluding thrombus. Plaques that have a high risk of
      rupture are called vulnerable plaques. Cardiovascular imaging provides a complementary
      diagnostic approach in the assessment of cardiovascular risk in patients. However, the lack
      of biological detection possibilities of current imaging technologies limits their predictive
      value. For instance, multi detector computed tomography (MDCT) is an excellent tool to
      visualize coronary atherosclerosis. However, individual risk assessment is still problematic.
      Which of the diagnosed atherosclerotic plaques will undergo plaque rupture and lead to acute
      vascular events is currently hard to predict. Potentially, serum biomarkers could help
      identify the patient at risk. A wide variety of prognostic markers related to atherosclerosis
      have been identified in the past to predict for cardiovascular events. Nevertheless, their
      predictive value in individual patients is still limited. A difficulty in serum biomarker
      research is the requirement of large patient cohorts to study the relation between event rate
      and serum biomarker levels. The necessity to perform lengthy and costly studies, hinders the
      translation of novel cardiovascular serum biomarkers into the clinic. An alternative approach
      could be to study the correlation between levels of serum biomarkers and the presence of
      atherosclerosis in the coronary arteries.

      Study objectives

      Primary objective of the present analysis is to investigate the predictive value of a variety
      of serum biomarkers to predict atherosclerosis in the coronary tree of patients undergoing
      cardiac MDCT.

      Design and Methods

      Patients undergoing cardiac MDCT are eligible for the study. Excluded are patients with acute
      coronary syndrome, hemodynamic instability, pregnancy, severe renal insufficiency, allergy
      for contrast medium and inability to obtain informed consent. Permission to store the serum
      samples for future analysis of new prognostic markers for cardiovascular events will be
      acquired from the patients. Written information is send to the patient at least 1 week prior
      to CT. The samples will be stored coded, at the Biobank Maastricht, for a maximum duration of
      15 years. Once measurements from the samples will be performed, the serum samples will be
      sent by the Biobank coded to the analyzing researchers, which have no access to the key file
      where codes are linked to the specific hospital identity number. This file will be stored by
      an independent researcher at the Cardiology department of the Maastricht University Medical
      Center. The assessment of atherosclerotic burden of the coronary tree will be performed by
      cardiac MDCT specialists blinded to the clinical data and serum biomarker outcome. Biomarker
      levels are correlated to the severity and amount of coronary artery disease as assessed by
      cardiac MDCT.
observational model: Cohort
time perspective: Cross-Sectional
measure: coronary artery disease
time frame: 1 year
description: The presence of any coronary atherosclerotic plaque as visible on cardiac CT.
The presence of any significant (≥50% luminal stenosis) coronary plaque in the coronary tree.
The number of atherosclerotic plaques in the coronary tree.
The calcium score (Agatston method).
Plaques are categorized as calcified (exclusively content with density >130 Hounsfield units), non-calcified (exclusively content with density <130 Hounsfield units), or mixed (characteristics of both calcified and non-calcified plaque).
arm group label: cardiac computed tomographic angiography
description: Patients refered for cardiac computed tomographic angiography by a cardiologist.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: H Crijns, M.D. P.h.D.
role: Principal Investigator
affiliation: Maastricht University Medical Center
last name: B Kietselaer, M.D. P.h.D.
role: Study Director
affiliation: Maastricht University Medical Center
last name: L Hofstra, M.D. P.h.D
role: Study Chair
affiliation: Maastricht University Medical Center
facility: 
country: Netherlands
citation: Mingels AM, Joosen IA, Versteylen MO, Laufer EM, Winkens MH, Wildberger JE, Van Dieijen-Visser MP, Hofstra L. High-sensitivity cardiac troponin T: risk stratification tool in patients with symptoms of chest discomfort. PLoS One. 2012;7(4):e35059. doi: 10.1371/journal.pone.0035059. Epub 2012 Apr 25.
PMID: 22558116
citation: Laufer EM, Mingels AM, Winkens MH, Joosen IA, Schellings MW, Leiner T, Wildberger JE, Narula J, Van Dieijen-Visser MP, Hofstra L. The extent of coronary atherosclerosis is associated with increasing circulating levels of high sensitive cardiac troponin T. Arterioscler Thromb Vasc Biol. 2010 Jun;30(6):1269-75. doi: 10.1161/ATVBAHA.109.200394. Epub 2010 Mar 18.
PMID: 20299689
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Coronary Stenosis