<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/NCT02236923</url>
  </required_header>
  <id_info>
    <org_study_id>NICOR-14-ACS-24</org_study_id>
    <nct_id>NCT02236923</nct_id>
  </id_info>
  <brief_title>Study of the Influence of the Moon and Seasons On Outcomes Following Surgery To Repair Ascending Aortic Dissection</brief_title>
  <acronym>ACS-MOON-1</acronym>
  <official_title>The Influence of Lunar Cycle On Hospital Outcomes Following Ascending Aortic Dissection Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>22EON</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Cardiovascular Outcomes Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>22EON</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter&#xD;
      length of stay in patients undergoing repair of aortic dissection, after adjusting for&#xD;
      seasonal effects, demographics and cardiovascular risk factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to determine whether the findings of Shuhaiber et al.&#xD;
      [2013] (see citations) may be confirmed using national audit data from the United Kingdom.&#xD;
&#xD;
      A cohort of all acute ascending aortic dissection repair surgeries will be extracted from the&#xD;
      National Adult Cardiac Surgery Audit (NACSA) database. The current dataset version 4.12,&#xD;
      available for download from the website of the National Institute for Cardiovascular Outcomes&#xD;
      Research (see links), contains 168 fields that detail pre-operative patient characteristics,&#xD;
      operative details and post-operative outcomes. The dataset is revised intermittently to meet&#xD;
      the requirements of users and to respond to changes in the management of adult cardiac&#xD;
      surgery; however, the fields to be analysed in this study have not been subject to any&#xD;
      documented revisions. The extracted data are to be cleaned using version 9.9 of the NACSA&#xD;
      cleaning algorithm.&#xD;
&#xD;
      Seasons are to be coded in the same way as in the published study: autumn (September 21&#xD;
      through December 20), winter (December 21 through March 21), spring (March 22 through June&#xD;
      21) and summer (June 22 through September 20).&#xD;
&#xD;
      Three definitions are to be used for the phases of the moon. The first definition mirrors&#xD;
      that employed in the motivating work: each lunar cycle from new moon to new moon is to be&#xD;
      split into four parts and labelled &quot;New&quot;, &quot;Waxing&quot;, &quot;Full&quot; and &quot;Waning&quot;. The second&#xD;
      definition centers each of those four labels around the named event: i.e., the &quot;New&quot; period&#xD;
      is to be centered around the new moon event itself, instead of starting on the day of a new&#xD;
      moon as in the first definition. The third definition will split the lunar cycle into 8&#xD;
      event-centred periods, called &quot;New&quot;, &quot;Waxing crescent&quot;, &quot;First quarter&quot;, &quot;Waxing gibbous&quot;,&#xD;
      &quot;Full&quot;, &quot;Waning gibbous&quot;, &quot;Last quarter&quot; and &quot;Waning crescent&quot;.&#xD;
&#xD;
      There is no need to explore the individual univariate relationships of predictors to outcomes&#xD;
      in this work, given its limited purpose to confirm the earlier multivariate findings. The&#xD;
      relationship between the environmental factors (seasons and the lunar cycle) and in-hospital&#xD;
      mortality will be examined using multivariate logistic regression, controlling for&#xD;
      demographic and mortality risk factors. The specific variables that can be included in common&#xD;
      with the earlier work are age, sex, hypertension, diabetes, renal failure, and an indicator&#xD;
      of weekend admission. The national audit does not include information on dyslipidaemia, but&#xD;
      it is felt that its exclusion from our model will not effect the comparability of our work to&#xD;
      the earlier study because none of the earlier published models showed any effect of&#xD;
      dyslipidaemia on surgical outcomes. The relationship of the environmental factors to Length&#xD;
      of stay (LOS) in survivors will be examined using a multivariate linear regression that&#xD;
      includes the same risk factors as in the mortality model. As in the published study, LOS will&#xD;
      be transformed to the natural logarithmic scale prior to analysis.&#xD;
&#xD;
      We will run all analyses with and without a European system for cardiac operative risk&#xD;
      evaluation score (EuroSCORE) II risk adjustment. The EuroSCORE II was developed specifically&#xD;
      to adjust for risk of in-hospital mortality. It will be employed here despite its absence&#xD;
      from the published models to ensure that risk adjustment prior to estimation of the&#xD;
      contributions of the environmental factors will be as thorough as reasonably possible.&#xD;
&#xD;
      All analyses will be performed using R version 3.1.0. Environmental factors will be&#xD;
      calculated using the lunar package available from the CRAN software repository.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 1998</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>All cause in-hospital mortality</measure>
    <time_frame>During hospital stay, an expected average of 8 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of stay in hospital among survivors to discharge</measure>
    <time_frame>During hospital stay, an expected average of 18 days</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2684</enrollment>
  <condition>Aneurysm, Dissecting</condition>
  <condition>Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>Group A: Single procedure</arm_group_label>
    <description>Group A consists of patients recorded as having only had an ascending aortic dissection repair procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Multiple procedures</arm_group_label>
    <description>Group B consists of patients who had an ascending aortic dissection repair procedure together with any other surgical intervention.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All acute ascending aortic dissection repair procedures recorded in the United Kingdom's&#xD;
        National Adult Cardiac Surgery Audit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acute dissection specified in aortic pathology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  missing data in the demographic covariates (age, sex)&#xD;
&#xD;
          -  missing data in the medical history (hypertension, diabetes, renal failure)&#xD;
&#xD;
          -  missing surgical procedure date&#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>Emmanuel Lazaridis, PhD, LLB</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute for Cardiovascular Outcomes Research</name>
      <address>
        <city>London</city>
        <zip>W1T 7HA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Shuhaiber JH, Fava JL, Shin T, Dobrilovic N, Ehsan A, Bert A, Sellke F. The influence of seasons and lunar cycle on hospital outcomes following ascending aortic dissection repair. Interact Cardiovasc Thorac Surg. 2013 Nov;17(5):818-22. doi: 10.1093/icvts/ivt299. Epub 2013 Jul 9.</citation>
    <PMID>23838340</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiovascular</keyword>
  <keyword>surgery</keyword>
  <keyword>ascending aorta</keyword>
  <keyword>aortic dissection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Dissection</mesh_term>
    <mesh_term>Dissection, Ascending Aorta</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/NCT02236923
org study id: NICOR-14-ACS-24
nct id: NCT02236923
lead sponsor: 
collaborator: 
has dmc: No
That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter
      length of stay in patients undergoing repair of aortic dissection, after adjusting for
      seasonal effects, demographics and cardiovascular risk factors.
The primary objective of this study is to determine whether the findings of Shuhaiber et al.
      [2013] (see citations) may be confirmed using national audit data from the United Kingdom.

      A cohort of all acute ascending aortic dissection repair surgeries will be extracted from the
      National Adult Cardiac Surgery Audit (NACSA) database. The current dataset version 4.12,
      available for download from the website of the National Institute for Cardiovascular Outcomes
      Research (see links), contains 168 fields that detail pre-operative patient characteristics,
      operative details and post-operative outcomes. The dataset is revised intermittently to meet
      the requirements of users and to respond to changes in the management of adult cardiac
      surgery; however, the fields to be analysed in this study have not been subject to any
      documented revisions. The extracted data are to be cleaned using version 9.9 of the NACSA
      cleaning algorithm.

      Seasons are to be coded in the same way as in the published study: autumn (September 21
      through December 20), winter (December 21 through March 21), spring (March 22 through June
      21) and summer (June 22 through September 20).

      Three definitions are to be used for the phases of the moon. The first definition mirrors
      that employed in the motivating work: each lunar cycle from new moon to new moon is to be
      split into four parts and labelled "New", "Waxing", "Full" and "Waning". The second
      definition centers each of those four labels around the named event: i.e., the "New" period
      is to be centered around the new moon event itself, instead of starting on the day of a new
      moon as in the first definition. The third definition will split the lunar cycle into 8
      event-centred periods, called "New", "Waxing crescent", "First quarter", "Waxing gibbous",
      "Full", "Waning gibbous", "Last quarter" and "Waning crescent".

      There is no need to explore the individual univariate relationships of predictors to outcomes
      in this work, given its limited purpose to confirm the earlier multivariate findings. The
      relationship between the environmental factors (seasons and the lunar cycle) and in-hospital
      mortality will be examined using multivariate logistic regression, controlling for
      demographic and mortality risk factors. The specific variables that can be included in common
      with the earlier work are age, sex, hypertension, diabetes, renal failure, and an indicator
      of weekend admission. The national audit does not include information on dyslipidaemia, but
      it is felt that its exclusion from our model will not effect the comparability of our work to
      the earlier study because none of the earlier published models showed any effect of
      dyslipidaemia on surgical outcomes. The relationship of the environmental factors to Length
      of stay (LOS) in survivors will be examined using a multivariate linear regression that
      includes the same risk factors as in the mortality model. As in the published study, LOS will
      be transformed to the natural logarithmic scale prior to analysis.

      We will run all analyses with and without a European system for cardiac operative risk
      evaluation score (EuroSCORE) II risk adjustment. The EuroSCORE II was developed specifically
      to adjust for risk of in-hospital mortality. It will be employed here despite its absence
      from the published models to ensure that risk adjustment prior to estimation of the
      contributions of the environmental factors will be as thorough as reasonably possible.

      All analyses will be performed using R version 3.1.0. Environmental factors will be
      calculated using the lunar package available from the CRAN software repository.
observational model: Cohort
time perspective: Retrospective
measure: All cause in-hospital mortality
time frame: During hospital stay, an expected average of 8 days
measure: Length of stay in hospital among survivors to discharge
time frame: During hospital stay, an expected average of 18 days
arm group label: Group A: Single procedure
description: Group A consists of patients recorded as having only had an ascending aortic dissection repair procedure.
arm group label: Group B: Multiple procedures
description: Group B consists of patients who had an ascending aortic dissection repair procedure together with any other surgical intervention.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emmanuel Lazaridis, PhD, LLB
role: Principal Investigator
affiliation: University College, London
facility: 
country: United Kingdom
citation: Shuhaiber JH, Fava JL, Shin T, Dobrilovic N, Ehsan A, Bert A, Sellke F. The influence of seasons and lunar cycle on hospital outcomes following ascending aortic dissection repair. Interact Cardiovasc Thorac Surg. 2013 Nov;17(5):818-22. doi: 10.1093/icvts/ivt299. Epub 2013 Jul 9.
PMID: 23838340
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Dissection
mesh term: Dissection, Ascending Aorta