<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/NCT03292354</url>
  </required_header>
  <id_info>
    <org_study_id>NL59507.068.16</org_study_id>
    <nct_id>NCT03292354</nct_id>
  </id_info>
  <brief_title>Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography</brief_title>
  <acronym>PeopleCT</acronym>
  <official_title>Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography</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>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>
      Cardiac computed tomography (CCT) is one of the standard non-invasive imaging techniques&#xD;
      allowing imaging of the heart and coronary arteries with a high temporal and spatial&#xD;
      resolution. The high sensitivity and negative predictive value (NPV) of coronary CT&#xD;
      angiography (CCTA) make it a valuable tool in the assessment of coronary artery disease (CAD)&#xD;
      in patients with low to intermediate risk for CAD, especially to rule out CAD. This risk&#xD;
      stratification can be done with help of multiple different risk-calculators (e.g. the updated&#xD;
      Diamond-Forrester model by Genders et al. 2012). These calculators take different variables&#xD;
      into account, e.g. advanced age, gender, blood pressure, diabetes mellitus (DM), lipid&#xD;
      profile and smoking.&#xD;
&#xD;
      The aim of CCTA is a high diagnostic accuracy, which depends on both optimal intravascular&#xD;
      enhancement (in Hounsfield Units; minimal 325 HU) and contrast-to-noise ratio (CNR). Optimal&#xD;
      intravascular enhancement and CNR depend on different factors such as scan technique (e.g.&#xD;
      tube voltage, tube potential), parameters of the administered contrast material (CM) and&#xD;
      patient related factors (e.g. cardiac output (CO), body weight (BW)).&#xD;
&#xD;
      Patients with cardiac diseases often have multiple risk factors for developing contrast&#xD;
      induced nephropathy (CIN), e.g. diabetes mellitus, advanced age, hypertension and chronic&#xD;
      kidney disease. Although the relationship between CTA and CIN has recently come to discussion&#xD;
      (AMACING trial; Nijssen et al. 2017), it is still desirable to minimise the CM volume used in&#xD;
      these patients. One method to reduce the CM volume is to personalise the injection protocols.&#xD;
      The personalisation of injection protocols to the individual patient is gaining more&#xD;
      attention in the field of CT imaging. The goal is to individualise the injection protocols to&#xD;
      a level, where the patient only receives the minimal amount of CM needed to acquire a&#xD;
      diagnostic scan, while maintaining a diagnostic image quality. Many techniques are available&#xD;
      and have been studied, e.g. adjustment of CM volume to scan protocol, CO, lean body weight&#xD;
      (LBW) and BW.&#xD;
&#xD;
      However, no data is available on which of these is the most beneficial method for the&#xD;
      personalisation of CM injection protocols. Therefore, the aim of this study is to assess the&#xD;
      performance of three different personalized injection protocols (based on CO, LBW and BW) in&#xD;
      CCTA with regard to image quality in comparison to previously used protocols in our&#xD;
      department. We hypothesize that the personalized injection protocols will be non-inferior,&#xD;
      provide a homogenous coronary enhancement (less non-diagnostic scans) in patients, and will&#xD;
      account for a reduction of CM volume in our department in comparison to the previously used&#xD;
      protocols.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiac diseases still are the leading cause of death in the western world. Besides the high&#xD;
      mortality of the cardiac disease itself, recent studies have shown an increasing evidence of&#xD;
      the prognostic value of cardiac diseases, particularly coronary artery disease (CAD), in a&#xD;
      broad variety of other diseases. Especially in patients with oncological pathologies&#xD;
      undergoing radiotherapy or lung resection surgery [Ambrogi et al. 2003; Kanzaki et al. 2017;&#xD;
      Khakoo et al. 2008; Basacaraju et al. 2002; Fajardo et al. 1972]. Cardiac computed tomography&#xD;
      angiography (CCTA) is one of the standard non-invasive imaging techniques allowing imaging of&#xD;
      the heart and coronary arteries with a high temporal and spatial resolution. The high&#xD;
      sensitivity and negative predictive value (NPV) of CCTA make it a valuable tool in the&#xD;
      assessment of CAD. Especially to rule out CAD in patients with low to intermediate risk for&#xD;
      CAD [Hendel et al. 2006; Goldstein et al. 2011; Budoff et al. 2008; Meijboom et al. 2008;&#xD;
      Roffi et al. 2016].&#xD;
&#xD;
      The aim of CCTA is to achieve a high diagnostic accuracy, which depends on both optimal&#xD;
      intravascular enhancement (in Hounsfield Units (HU); minimal 325 HU) and contrast-to-noise&#xD;
      ratio (CNR). Optimal intravascular enhancement and CNR depend on multiple factors, such as&#xD;
      scan technique (e.g. tube voltage (kV) and tube potential), parameters of the administered&#xD;
      contrast material (CM) (e.g. concentration, flow rate) and patient related factors (e.g. body&#xD;
      weight (BW), heart rate or cardiac output [CO]) [Bae et al. 2004; Awai et al. 2004].&#xD;
      Dedicated CT protocols are necessary to image the heart and the coronary arteries. These&#xD;
      protocols require a correlation to the patient's electrocardiogram (ECG) in order to minimize&#xD;
      cardiac motion and deliver a sharp image of the heart and coronary arteries. Depending on the&#xD;
      heart rate of the patient, the scan can either be a prospectively ECG-triggered high-pitch or&#xD;
      adaptive sequence, or retrospectively ECG-gated helical scan.&#xD;
&#xD;
      Patients with cardiac diseases often have multiple risk factors for developing contrast&#xD;
      induced nephropathy (CIN), e.g. diabetes mellitus (DM), advanced age, hypertension,&#xD;
      cardiovascular disease and chronic kidney disease. Although the relationship between CTA and&#xD;
      CIN has recently come to discussion (AMACING trial; Nijssen et al. 2017), it is still&#xD;
      desirable to minimise the CM volume used in these patients. Multiple strategies have been&#xD;
      studied to reduce CM volume in CTA imaging [Kok et al 2016; Kok et al. 2015; Kok et al. 2016;&#xD;
      Kok et al. 2016, Mihl et al. 2016; Seehofnerova et al. 2015; Hendriks et al. 2016]. For&#xD;
      instance, lowering tube voltage to achieve a higher attenuation, the latter explained by the&#xD;
      fact that mean photon energy of lower tube voltage settings in the x-ray beam moves closer to&#xD;
      the K-edge of iodine (33.2 keV).&#xD;
&#xD;
      The personalisation of injection protocols to the individual patient is gaining more&#xD;
      attention in CT imaging, and the goal is to individualise the injection protocols to a level,&#xD;
      where the patient only receives the minimal amount of CM needed to make a diagnostic scan&#xD;
      with a diagnostic image quality. Besides the techniques mentioned above, other techniques are&#xD;
      possible, e.g. adjustment according to patients CO, lean body weight (LBW), and BW.&#xD;
&#xD;
      Both blood volume and CO increase with an increasing BW. When CO increases, the distribution&#xD;
      of CM is also increased. On one hand this results in a fastened test bolus arrival, on the&#xD;
      other hand in a decreased and shortened intravascular attenuation profile (in comparison to a&#xD;
      decreased CO) [Bae KT 2010]. Therefore, both timing and CM volume can be adjusted to CO in&#xD;
      order to achieve a similar intravascular attenuation profile.&#xD;
&#xD;
      LBW is a measurement for body fat percentage. It is known that fatty tissue is not as well&#xD;
      vascularised in comparison to muscle tissue. Thus with increasing BW due to fatty tissue, the&#xD;
      blood volume does not increase linear to BW. For instance, patients with a high BW due to&#xD;
      increased muscle tissue, need more CM volume compared to patients with a high BW due to fatty&#xD;
      tissue. The concept of LBW accounts for this fact [Bae KT 2010].&#xD;
&#xD;
      When adjusting CM volume to BW, less CM volume is needed with a lower BW in comparison to a&#xD;
      higher BW, due to the decreased blood volume and CO [Bae KT 2010].&#xD;
&#xD;
      The tube voltage, set by automated tube voltage selection (ATVS, CAREkV, Siemens, Berlin,&#xD;
      Germany), needs to be taken into account as well. CAREkV is a software program which chooses&#xD;
      the optimal tube voltage (kV) and tube current (mAs) settings for the individual patient,&#xD;
      based on their topograms, while maintaining a diagnostic image quality. Lower kV settings&#xD;
      result in a higher intravascular enhancement if the same amount of CM is used, thus giving&#xD;
      the potential to decrease CM volume in lower kV settings.&#xD;
&#xD;
      Since no data exist on the optimal method of choice, the aim of this study is to assess the&#xD;
      performance of three personalized injection protocols (CO, LBW and BW) in CCTA, in comparison&#xD;
      to previously used protocols, with regard to image quality. Secondly we want to assess the&#xD;
      presence and severity of CAD in patients undergoing CCTA with help of the coronary artery&#xD;
      disease reporting and data system (CAD-RADS).&#xD;
&#xD;
      A total of 330 patients will be included in this prospectively observer blinded randomized&#xD;
      controlled non-inferiority trial. All patients will be randomised in one of three groups (CO,&#xD;
      LBW and BW) with help of a randomisation software program (ALEA). The control group will&#xD;
      consist of 110 consecutive patients who will be included retrospectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Actual">September 14, 2018</completion_date>
  <primary_completion_date type="Actual">September 14, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>All investigators who assess the image quality will be blinded to the assigned contrast media protocol. Only the technicians who complete the scan and injection protocol will be unblinded for the contrast media protocol chosen.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Image quality</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate the performance of the individualised injection protocols in CCTA, with regard to intravascular attenuation (minimal 325 HU) and compare them with the control group (non-inferiority).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective image quality</measure>
    <time_frame>1 year</time_frame>
    <description>The performance of the individualised injection protocols in CCTA with regard to objective image quality (image noise, CNR and SNR as calculated from the intravascular enhancement), compared to the standard injection protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subjective image quality</measure>
    <time_frame>1 year</time_frame>
    <description>The performance of the individualised injection protocols in CCTA with regard to subjective image quality (4-point Likert scale), compared to the standard injection protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coronary artery disease</measure>
    <time_frame>1 year</time_frame>
    <description>To assess the presence and severity of coronary artery disease (CAD) with help of the CAD-RADS classification</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">327</enrollment>
  <condition>Coronary Artery Calcification</condition>
  <condition>Cardiac Disease</condition>
  <arm_group>
    <arm_group_label>Body Weight (BW)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on body weight.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cardiac output (CO)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on cardiac output.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lean Body weight (LBW)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on Lean Body Weight.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group will be included retrospectively and have received the standard CM injection protocol previously used in our department.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Contrast media administration</intervention_name>
    <description>All patients will receive contrast media with a concentration of 300 mg I/mL (Iopromide 300). The flowrate and volume will be calculated with help of the different formulas belonging to the three different arms.</description>
    <arm_group_label>Body Weight (BW)</arm_group_label>
    <arm_group_label>Cardiac output (CO)</arm_group_label>
    <arm_group_label>Lean Body weight (LBW)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred for CCTA;&#xD;
&#xD;
          -  Age &gt; 18 years;&#xD;
&#xD;
          -  Informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to perform a breath hold for the expected scan time;&#xD;
&#xD;
          -  Hemodynamic instability;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Renal insufficiency (defined as glomerular filtration rate (GFR) &lt; 30 mL/min);&#xD;
&#xD;
          -  Iodine allergy;&#xD;
&#xD;
          -  Age &lt; 18 years;&#xD;
&#xD;
          -  Absence of informed consent.&#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>Joachim E Wildberger, Prof.dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <state>Zuid-Limburg</state>
        <zip>6202AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
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  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maastricht University Medical Center</investigator_affiliation>
    <investigator_full_name>Joachim Wildberger</investigator_full_name>
    <investigator_title>Prof.Dr. J.E. Wildberger</investigator_title>
  </responsible_party>
  <keyword>Coronary Computed Tomography Angiography</keyword>
  <keyword>Image Quality</keyword>
  <keyword>Contrast Media Reduction</keyword>
  <keyword>Personalised Injection Protocols</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</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/NCT03292354
org study id: NL59507.068.16
nct id: NCT03292354
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cardiac computed tomography (CCT) is one of the standard non-invasive imaging techniques
      allowing imaging of the heart and coronary arteries with a high temporal and spatial
      resolution. The high sensitivity and negative predictive value (NPV) of coronary CT
      angiography (CCTA) make it a valuable tool in the assessment of coronary artery disease (CAD)
      in patients with low to intermediate risk for CAD, especially to rule out CAD. This risk
      stratification can be done with help of multiple different risk-calculators (e.g. the updated
      Diamond-Forrester model by Genders et al. 2012). These calculators take different variables
      into account, e.g. advanced age, gender, blood pressure, diabetes mellitus (DM), lipid
      profile and smoking.

      The aim of CCTA is a high diagnostic accuracy, which depends on both optimal intravascular
      enhancement (in Hounsfield Units; minimal 325 HU) and contrast-to-noise ratio (CNR). Optimal
      intravascular enhancement and CNR depend on different factors such as scan technique (e.g.
      tube voltage, tube potential), parameters of the administered contrast material (CM) and
      patient related factors (e.g. cardiac output (CO), body weight (BW)).

      Patients with cardiac diseases often have multiple risk factors for developing contrast
      induced nephropathy (CIN), e.g. diabetes mellitus, advanced age, hypertension and chronic
      kidney disease. Although the relationship between CTA and CIN has recently come to discussion
      (AMACING trial; Nijssen et al. 2017), it is still desirable to minimise the CM volume used in
      these patients. One method to reduce the CM volume is to personalise the injection protocols.
      The personalisation of injection protocols to the individual patient is gaining more
      attention in the field of CT imaging. The goal is to individualise the injection protocols to
      a level, where the patient only receives the minimal amount of CM needed to acquire a
      diagnostic scan, while maintaining a diagnostic image quality. Many techniques are available
      and have been studied, e.g. adjustment of CM volume to scan protocol, CO, lean body weight
      (LBW) and BW.

      However, no data is available on which of these is the most beneficial method for the
      personalisation of CM injection protocols. Therefore, the aim of this study is to assess the
      performance of three different personalized injection protocols (based on CO, LBW and BW) in
      CCTA with regard to image quality in comparison to previously used protocols in our
      department. We hypothesize that the personalized injection protocols will be non-inferior,
      provide a homogenous coronary enhancement (less non-diagnostic scans) in patients, and will
      account for a reduction of CM volume in our department in comparison to the previously used
      protocols.
Cardiac diseases still are the leading cause of death in the western world. Besides the high
      mortality of the cardiac disease itself, recent studies have shown an increasing evidence of
      the prognostic value of cardiac diseases, particularly coronary artery disease (CAD), in a
      broad variety of other diseases. Especially in patients with oncological pathologies
      undergoing radiotherapy or lung resection surgery [Ambrogi et al. 2003; Kanzaki et al. 2017;
      Khakoo et al. 2008; Basacaraju et al. 2002; Fajardo et al. 1972]. Cardiac computed tomography
      angiography (CCTA) is one of the standard non-invasive imaging techniques allowing imaging of
      the heart and coronary arteries with a high temporal and spatial resolution. The high
      sensitivity and negative predictive value (NPV) of CCTA make it a valuable tool in the
      assessment of CAD. Especially to rule out CAD in patients with low to intermediate risk for
      CAD [Hendel et al. 2006; Goldstein et al. 2011; Budoff et al. 2008; Meijboom et al. 2008;
      Roffi et al. 2016].

      The aim of CCTA is to achieve a high diagnostic accuracy, which depends on both optimal
      intravascular enhancement (in Hounsfield Units (HU); minimal 325 HU) and contrast-to-noise
      ratio (CNR). Optimal intravascular enhancement and CNR depend on multiple factors, such as
      scan technique (e.g. tube voltage (kV) and tube potential), parameters of the administered
      contrast material (CM) (e.g. concentration, flow rate) and patient related factors (e.g. body
      weight (BW), heart rate or cardiac output [CO]) [Bae et al. 2004; Awai et al. 2004].
      Dedicated CT protocols are necessary to image the heart and the coronary arteries. These
      protocols require a correlation to the patient's electrocardiogram (ECG) in order to minimize
      cardiac motion and deliver a sharp image of the heart and coronary arteries. Depending on the
      heart rate of the patient, the scan can either be a prospectively ECG-triggered high-pitch or
      adaptive sequence, or retrospectively ECG-gated helical scan.

      Patients with cardiac diseases often have multiple risk factors for developing contrast
      induced nephropathy (CIN), e.g. diabetes mellitus (DM), advanced age, hypertension,
      cardiovascular disease and chronic kidney disease. Although the relationship between CTA and
      CIN has recently come to discussion (AMACING trial; Nijssen et al. 2017), it is still
      desirable to minimise the CM volume used in these patients. Multiple strategies have been
      studied to reduce CM volume in CTA imaging [Kok et al 2016; Kok et al. 2015; Kok et al. 2016;
      Kok et al. 2016, Mihl et al. 2016; Seehofnerova et al. 2015; Hendriks et al. 2016]. For
      instance, lowering tube voltage to achieve a higher attenuation, the latter explained by the
      fact that mean photon energy of lower tube voltage settings in the x-ray beam moves closer to
      the K-edge of iodine (33.2 keV).

      The personalisation of injection protocols to the individual patient is gaining more
      attention in CT imaging, and the goal is to individualise the injection protocols to a level,
      where the patient only receives the minimal amount of CM needed to make a diagnostic scan
      with a diagnostic image quality. Besides the techniques mentioned above, other techniques are
      possible, e.g. adjustment according to patients CO, lean body weight (LBW), and BW.

      Both blood volume and CO increase with an increasing BW. When CO increases, the distribution
      of CM is also increased. On one hand this results in a fastened test bolus arrival, on the
      other hand in a decreased and shortened intravascular attenuation profile (in comparison to a
      decreased CO) [Bae KT 2010]. Therefore, both timing and CM volume can be adjusted to CO in
      order to achieve a similar intravascular attenuation profile.

      LBW is a measurement for body fat percentage. It is known that fatty tissue is not as well
      vascularised in comparison to muscle tissue. Thus with increasing BW due to fatty tissue, the
      blood volume does not increase linear to BW. For instance, patients with a high BW due to
      increased muscle tissue, need more CM volume compared to patients with a high BW due to fatty
      tissue. The concept of LBW accounts for this fact [Bae KT 2010].

      When adjusting CM volume to BW, less CM volume is needed with a lower BW in comparison to a
      higher BW, due to the decreased blood volume and CO [Bae KT 2010].

      The tube voltage, set by automated tube voltage selection (ATVS, CAREkV, Siemens, Berlin,
      Germany), needs to be taken into account as well. CAREkV is a software program which chooses
      the optimal tube voltage (kV) and tube current (mAs) settings for the individual patient,
      based on their topograms, while maintaining a diagnostic image quality. Lower kV settings
      result in a higher intravascular enhancement if the same amount of CM is used, thus giving
      the potential to decrease CM volume in lower kV settings.

      Since no data exist on the optimal method of choice, the aim of this study is to assess the
      performance of three personalized injection protocols (CO, LBW and BW) in CCTA, in comparison
      to previously used protocols, with regard to image quality. Secondly we want to assess the
      presence and severity of CAD in patients undergoing CCTA with help of the coronary artery
      disease reporting and data system (CAD-RADS).

      A total of 330 patients will be included in this prospectively observer blinded randomized
      controlled non-inferiority trial. All patients will be randomised in one of three groups (CO,
      LBW and BW) with help of a randomisation software program (ALEA). The control group will
      consist of 110 consecutive patients who will be included retrospectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
masking description: All investigators who assess the image quality will be blinded to the assigned contrast media protocol. Only the technicians who complete the scan and injection protocol will be unblinded for the contrast media protocol chosen.
measure: Image quality
time frame: 1 year
description: To evaluate the performance of the individualised injection protocols in CCTA, with regard to intravascular attenuation (minimal 325 HU) and compare them with the control group (non-inferiority).
measure: Objective image quality
time frame: 1 year
description: The performance of the individualised injection protocols in CCTA with regard to objective image quality (image noise, CNR and SNR as calculated from the intravascular enhancement), compared to the standard injection protocol.
measure: subjective image quality
time frame: 1 year
description: The performance of the individualised injection protocols in CCTA with regard to subjective image quality (4-point Likert scale), compared to the standard injection protocol.
measure: Coronary artery disease
time frame: 1 year
description: To assess the presence and severity of coronary artery disease (CAD) with help of the CAD-RADS classification
arm group label: Body Weight (BW)
arm group type: Active Comparator
description: Patients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on body weight.
arm group label: Cardiac output (CO)
arm group type: Active Comparator
description: Patients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on cardiac output.
arm group label: Lean Body weight (LBW)
arm group type: Active Comparator
description: Patients referred for CCTA in this group receive a personalised contrast media protocol. Contrast media administration based on Lean Body Weight.
arm group label: Control group
arm group type: No Intervention
description: Patients in this group will be included retrospectively and have received the standard CM injection protocol previously used in our department.
intervention type: Other
intervention name: Contrast media administration
description: All patients will receive contrast media with a concentration of 300 mg I/mL (Iopromide 300). The flowrate and volume will be calculated with help of the different formulas belonging to the three different arms.
arm group label: Body Weight (BW)
arm group label: Cardiac output (CO)
arm group label: Lean Body weight (LBW)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joachim E Wildberger, Prof.dr.
role: Principal Investigator
affiliation: Maastricht University Medical Center
facility: 
country: Netherlands
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responsible party type: Principal Investigator
investigator affiliation: Maastricht University Medical Center
investigator full name: Joachim Wildberger
investigator title: Prof.Dr. J.E. Wildberger
mesh term: Heart Diseases