<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/NCT02208648</url>
  </required_header>
  <id_info>
    <org_study_id>14/P/108</org_study_id>
    <nct_id>NCT02208648</nct_id>
  </id_info>
  <brief_title>Coronary Assessment for Mortality Prediction</brief_title>
  <acronym>CAMP</acronym>
  <official_title>Coronary Assessment for Mortality Prediction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Plymouth NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Plymouth NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will investigate whether the presence of coronary artery calcium as demonstrated on&#xD;
      pre-operative, thoracic staging Computed Tomography (CT) is an independent risk factor for 90&#xD;
      day mortality in patients undergoing major abdominal surgery.&#xD;
&#xD;
      The study research question: Do higher levels of coronary calcification correlate to an&#xD;
      increased risk of post-operative mortality in patients undergoing major abdominal surgery?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study uses a retrospective observational study design.&#xD;
&#xD;
      Due to the nature of the subject of the study and its retrospective design no patient contact&#xD;
      will be necessary and all imaging reviewed will have been acquired as part of their routine&#xD;
      level of care.&#xD;
&#xD;
      Plan for the gathering of study data&#xD;
&#xD;
      A list of patients with the following surgical codes will be identified from the hospital&#xD;
      surgical performance database to create retrospective dataset of 5 years' worth of cases (to&#xD;
      December 2013). This date range may be extended to ensure an adequate sample size. :&#xD;
&#xD;
      Surgical codes (Healthcare Resource Groups (HRG) codes) to be included:&#xD;
&#xD;
      F31 Large Intestine - Complex Procedures F32 Large Intestine - Very Major Procedures F33&#xD;
      Large Intestine - Major Procedures with complications and comorbidities (w cc) F34 Large&#xD;
      Intestine - Major Procedures without complications and comorbidities (w/o cc) F36 Large&#xD;
      Intestinal Disorders &gt;69 or w cc F37 Large Intestinal Disorders &lt;70 w/o cc&#xD;
&#xD;
      F41 General Abdominal - Very Major or Major Procedures patients over 69 years of age (&gt;69) or&#xD;
      w cc F42 General Abdominal - Very Major or Major Procedures patients under 70 years of age&#xD;
      (&lt;70) w/o cc F46 General Abdominal Disorders &gt;69 or w cc F47 General Abdominal Disorders &lt;70&#xD;
      w/o cc&#xD;
&#xD;
      Cross-reference with Somerset Cancer Register and remove any who were not recognised as&#xD;
      having bowel cancer.&#xD;
&#xD;
      This patient list will be cross-referenced with records of peri-operative mortality (within&#xD;
      90 days)&#xD;
&#xD;
      Propensity match each deceased patient to a patient who survived beyond 90 days. Our matching&#xD;
      rules will be in descending order of importance :&#xD;
&#xD;
        -  HRG code&#xD;
&#xD;
        -  gender,&#xD;
&#xD;
        -  cancer staging&#xD;
&#xD;
        -  Age+/-5yrs.&#xD;
&#xD;
        -  American Society of Anesthesiologists (ASA) Grade&#xD;
&#xD;
      Where there are multiple potential matches then this will be resolved by consultation between&#xD;
      the research team members.&#xD;
&#xD;
      Pairs of CT scans (deceased plus matched control) will be procured from WebPACS (Web Picture&#xD;
      Archival Communication System).&#xD;
&#xD;
      Scans will be anonymised and stored on a dedicated secure radiology research server.&#xD;
&#xD;
      Abbreviated Calcium scores will be generated for all patients in the trial by a trained&#xD;
      radiologist using the calcium scoring method. Calcium burden will be recorded on a scale of&#xD;
      1-12 . The radiologist will be blinded to the group that the patient belongs to, to minimise&#xD;
      bias.&#xD;
&#xD;
      Scans (deceased patients and matched controls) will be analysed in batches of 30 pairs.&#xD;
      Radiologist (s) will be blinded to group allocation. Scans will not be &quot;paired&quot; at the time&#xD;
      of reading.&#xD;
&#xD;
      Interim statistical analysis (of calcium scores) will be performed after each batch of scans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2014</start_date>
  <completion_date type="Actual">November 11, 2018</completion_date>
  <primary_completion_date type="Actual">November 11, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome measure is an abbreviated calcium score</measure>
    <time_frame>5 years</time_frame>
    <description>To investigate whether the presence and severity of coronary calcification identified on routine, pre-operative staging CT scans of the chest are an independent risk factor for patients undergoing major surgery. Techniques have now been validated where calcium scores can be estimated from routine CT scans of the chest (Shemesh et al. 2006).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the use of the calcium scoring technique in contrast enhanced studies.</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Peri-operative Mortality</condition>
  <condition>Coronary Artery Calcium</condition>
  <arm_group>
    <arm_group_label>Deceased</arm_group_label>
    <description>Peri-operative mortality (within 90 days). Pairs of CT scans (deceased plus matched control) will be anonymised and stored on a secure server. Abbreviated Calcium scores will be generated for all patients in the trial by a trained radiologist using a calcium scoring method. The radiologist will be blinded to the group that the patient belongs to, to minimise bias. Scans (deceased patients and matched controls) will be analysed in batches of 30 pairs. Radiologist (s) will be blinded to group allocation. Scans will not be &quot;paired&quot; at the time of reading.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matched control</arm_group_label>
    <description>Patients who survived beyond 90 days peri-operatively. Pairs of CT scans (deceased plus matched control) will be anonymised and stored on a secure server. Abbreviated Calcium scores will be generated for all patients in the trial by a trained radiologist using a calcium scoring method. The radiologist will be blinded to the group that the patient belongs to, to minimise bias. Scans (deceased patients and matched controls) will be analysed in batches of 30 pairs. Radiologist (s) will be blinded to group allocation. Scans will not be &quot;paired&quot; at the time of reading.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Plymouth Hospital NHS Trust patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adults ≥18yrs old&#xD;
&#xD;
          -  Major abdominal surgery (See HRG Codes)&#xD;
&#xD;
          -  Bowel Cancer&#xD;
&#xD;
          -  Elective admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 yrs old&#xD;
&#xD;
          -  No suitable matched patient&#xD;
&#xD;
          -  No CT Chest available&#xD;
&#xD;
          -  Emergency admission&#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>Carl Roobottom, MBChB(Hons)</last_name>
    <role>Study Chair</role>
    <affiliation>Plymouth Hospital NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Shemesh J, Henschke CI, Farooqi A, Yip R, Yankelevitz DF, Shaham D, Miettinen OS. Frequency of coronary artery calcification on low-dose computed tomography screening for lung cancer. Clin Imaging. 2006 May-Jun;30(3):181-5. doi: 10.1016/j.clinimag.2005.11.002.</citation>
    <PMID>16632153</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>September 3, 2019</last_update_submitted>
  <last_update_submitted_qc>September 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>coronary calcification</keyword>
  <keyword>Computed Tomography</keyword>
  <keyword>Coronary artery calcium</keyword>
  <keyword>calcium scores</keyword>
  <keyword>post-operative mortality</keyword>
  <!-- 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/NCT02208648
org study id: 14/P/108
nct id: NCT02208648
lead sponsor: 
has dmc: No
The study will investigate whether the presence of coronary artery calcium as demonstrated on
      pre-operative, thoracic staging Computed Tomography (CT) is an independent risk factor for 90
      day mortality in patients undergoing major abdominal surgery.

      The study research question: Do higher levels of coronary calcification correlate to an
      increased risk of post-operative mortality in patients undergoing major abdominal surgery?
The study uses a retrospective observational study design.

      Due to the nature of the subject of the study and its retrospective design no patient contact
      will be necessary and all imaging reviewed will have been acquired as part of their routine
      level of care.

      Plan for the gathering of study data

      A list of patients with the following surgical codes will be identified from the hospital
      surgical performance database to create retrospective dataset of 5 years' worth of cases (to
      December 2013). This date range may be extended to ensure an adequate sample size. :

      Surgical codes (Healthcare Resource Groups (HRG) codes) to be included:

      F31 Large Intestine - Complex Procedures F32 Large Intestine - Very Major Procedures F33
      Large Intestine - Major Procedures with complications and comorbidities (w cc) F34 Large
      Intestine - Major Procedures without complications and comorbidities (w/o cc) F36 Large
      Intestinal Disorders >69 or w cc F37 Large Intestinal Disorders <70 w/o cc

      F41 General Abdominal - Very Major or Major Procedures patients over 69 years of age (>69) or
      w cc F42 General Abdominal - Very Major or Major Procedures patients under 70 years of age
      (<70) w/o cc F46 General Abdominal Disorders >69 or w cc F47 General Abdominal Disorders <70
      w/o cc

      Cross-reference with Somerset Cancer Register and remove any who were not recognised as
      having bowel cancer.

      This patient list will be cross-referenced with records of peri-operative mortality (within
      90 days)

      Propensity match each deceased patient to a patient who survived beyond 90 days. Our matching
      rules will be in descending order of importance :

        -  HRG code

        -  gender,

        -  cancer staging

        -  Age+/-5yrs.

        -  American Society of Anesthesiologists (ASA) Grade

      Where there are multiple potential matches then this will be resolved by consultation between
      the research team members.

      Pairs of CT scans (deceased plus matched control) will be procured from WebPACS (Web Picture
      Archival Communication System).

      Scans will be anonymised and stored on a dedicated secure radiology research server.

      Abbreviated Calcium scores will be generated for all patients in the trial by a trained
      radiologist using the calcium scoring method. Calcium burden will be recorded on a scale of
      1-12 . The radiologist will be blinded to the group that the patient belongs to, to minimise
      bias.

      Scans (deceased patients and matched controls) will be analysed in batches of 30 pairs.
      Radiologist (s) will be blinded to group allocation. Scans will not be "paired" at the time
      of reading.

      Interim statistical analysis (of calcium scores) will be performed after each batch of scans.
observational model: Cohort
time perspective: Retrospective
measure: The primary outcome measure is an abbreviated calcium score
time frame: 5 years
description: To investigate whether the presence and severity of coronary calcification identified on routine, pre-operative staging CT scans of the chest are an independent risk factor for patients undergoing major surgery. Techniques have now been validated where calcium scores can be estimated from routine CT scans of the chest (Shemesh et al. 2006).
measure: To assess the use of the calcium scoring technique in contrast enhanced studies.
time frame: 5 years
arm group label: Deceased
description: Peri-operative mortality (within 90 days). Pairs of CT scans (deceased plus matched control) will be anonymised and stored on a secure server. Abbreviated Calcium scores will be generated for all patients in the trial by a trained radiologist using a calcium scoring method. The radiologist will be blinded to the group that the patient belongs to, to minimise bias. Scans (deceased patients and matched controls) will be analysed in batches of 30 pairs. Radiologist (s) will be blinded to group allocation. Scans will not be "paired" at the time of reading.
arm group label: Matched control
description: Patients who survived beyond 90 days peri-operatively. Pairs of CT scans (deceased plus matched control) will be anonymised and stored on a secure server. Abbreviated Calcium scores will be generated for all patients in the trial by a trained radiologist using a calcium scoring method. The radiologist will be blinded to the group that the patient belongs to, to minimise bias. Scans (deceased patients and matched controls) will be analysed in batches of 30 pairs. Radiologist (s) will be blinded to group allocation. Scans will not be "paired" at the time of reading.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carl Roobottom, MBChB(Hons)
role: Study Chair
affiliation: Plymouth Hospital NHS Trust
facility: 
country: United Kingdom
citation: Shemesh J, Henschke CI, Farooqi A, Yip R, Yankelevitz DF, Shaham D, Miettinen OS. Frequency of coronary artery calcification on low-dose computed tomography screening for lung cancer. Clin Imaging. 2006 May-Jun;30(3):181-5. doi: 10.1016/j.clinimag.2005.11.002.
PMID: 16632153
responsible party type: Sponsor