xml: <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/NCT05977413</url>
    </required_header>
    <id_info>
      <org_study_id>71202</org_study_id>
      <nct_id>NCT05977413</nct_id>
    </id_info>
    <brief_title>NOTIFY (New Observations Taking Information From Yesterday)</brief_title>
    <acronym>NOTIFY</acronym>
    <official_title>NOTIFY (New Observations Taking Information From Yesterday)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Patient-Centered Outcomes Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Stanford University</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>
        This trial will investigate whether notifying patients and their clinicians of the presence&#xD;
        of moderate or severe coronary artery calcium on a low-dose CT scan performed for lung cancer&#xD;
        screening results in a lower incidence of cardiovascular death, nonfatal myocardial&#xD;
        infarction, or nonfatal stroke as compared with usual care informed by clinical practice&#xD;
        guidelines.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 2024</start_date>
    <completion_date type="Anticipated">June 2030</completion_date>
    <primary_completion_date type="Anticipated">June 2030</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>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke</measure>
      <time_frame>6 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of All-cause Death</measure>
      <time_frame>6 years</time_frame>
      <description>Number (%) of participants in each treatment group with death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Cardiovascular Death</measure>
      <time_frame>6 years</time_frame>
      <description>Number (%) of participants in each treatment group with cardiovascular death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Nonfatal Myocardial Infarction</measure>
      <time_frame>6 years</time_frame>
      <description>Number (%) of participants in each treatment group with nonfatal myocardial infarction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Nonfatal Stroke</measure>
      <time_frame>6 years</time_frame>
      <description>Number (%) of participants in each treatment group with nonfatal stroke</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Initial lipid-lowering therapy prescription rate</measure>
      <time_frame>within 6 months of 1st notification</time_frame>
      <description>Number (%) of participants in each treatment group with active prescriptions of lipid-lowering therapy at 6 months following randomization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with active lipid-lowering therapy prescriptions</measure>
      <time_frame>At 18 months</time_frame>
      <description>Persistence of need for lipid-lowering therapy at 18 months following randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)</measure>
      <time_frame>6 years</time_frame>
      <description>Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Rate of Specific Statin Prescribed and Statin Dose</measure>
      <time_frame>1 year post randomization</time_frame>
      <description>Rate of prescription of specific statins at specific doses</description>
    </other_outcome>
    <other_outcome>
      <measure>Rate of Prescription of Non-statin Lipid-lowering Medications</measure>
      <time_frame>1 year post randomization</time_frame>
      <description>Rate of prescription of specific non-statins</description>
    </other_outcome>
    <other_outcome>
      <measure>Rate of Aspirin Prescription</measure>
      <time_frame>1 year post randomization</time_frame>
      <description>Rate of aspirin prescription by treatment group</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of Antihypertensive Medications</measure>
      <time_frame>1 year post randomization</time_frame>
      <description>Number of antihypertensive medications prescribed per participant by treatment group</description>
    </other_outcome>
    <other_outcome>
      <measure>Median LDL-C Concentration</measure>
      <time_frame>1 year post randomization</time_frame>
      <description>Median LDL cholesterol concentration by treatment group</description>
    </other_outcome>
    <other_outcome>
      <measure>Percentage of participants with LDL-C &lt;70 mg/dL</measure>
      <time_frame>1 year post randomization</time_frame>
      <description>Percentage of participants with LDL-C &lt;70 mg/dL by treatment group</description>
    </other_outcome>
    <other_outcome>
      <measure>Systolic blood pressure</measure>
      <time_frame>1 year post randomization</time_frame>
      <description>Median systolic blood pressure value in mmHg by treatment group</description>
    </other_outcome>
    <other_outcome>
      <measure>Percentage of participants with Systolic Blood Pressure &lt;130 mmHg</measure>
      <time_frame>1 year post randomization</time_frame>
      <description>Percentage of participants with systolic blood pressure &lt;130 mmHg by treatment group</description>
    </other_outcome>
    <other_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>1 year post randomization</time_frame>
      <description>Median body mass index value by treatment group</description>
    </other_outcome>
    <other_outcome>
      <measure>Total number of primary care clinical encounters during the trial</measure>
      <time_frame>6 years</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of cardiology encounters</measure>
      <time_frame>6 years</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of cardiovascular diagnostic noninvasive tests</measure>
      <time_frame>6 years</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40000</enrollment>
    <condition>Atherosclerotic Cardiovascular Disease</condition>
    <arm_group>
      <arm_group_label>Notification of CAC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For patients randomized to the notification of CAC arm (NC), primary clinicians will be notified that with the assistance of a deep-learning algorithm, one of their patients was found to have a CAC score &gt;100 AU. The notification will include an image taken from the CT scan with CAC clearly marked. The notification will also include American Heart Association/American College of Cardiology 2a recommendation to initiate lipid lowering therapy (usually statin) given the presence of moderate-severe CAC.&#xD;
  Patients randomized to notification will receive messages (via EHR portal-based messages, text, or US postal mail) with notification of CAC presence on their LDCT, images showing the presence of CAC from their previous chest CT clearly marked, the recommendation to discuss statin or other lipid-lowering therapy with their clinician, and a link to a patient-friendly website about CAC and risk factor control. There will be reminder messages sent at 3 weeks and 12 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients randomized to Usual Care will receive usual medical care provided by their clinician informed by widely publicized clinical practice guidelines.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Notification of CAC</intervention_name>
      <description>Provider and patient are notified of coronary artery calcium present on patient's CT scan. Notification includes a personalized image of CAC from the patient's CT scan performed for lung cancer screening.</description>
      <arm_group_label>Notification of CAC</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Usual Care</intervention_name>
      <description>Patients randomized to Usual Care will receive usual medical care provided by their clinician informed by widely publicized clinical practice guidelines.</description>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 50-84 years&#xD;
  &#xD;
            -  No known ASCVD&#xD;
  &#xD;
            -  Lung cancer screenee with low dose CT scan (LDCT) within the last 5 years&#xD;
  &#xD;
            -  Coronary artery calcium (CAC) score on LDCT &gt;100 Agatston units (AU)&#xD;
  &#xD;
            -  Not taking a statin or other lipid-lowering therapy (e.g., ezetimibe, bempedoic acid,&#xD;
               or PCSK9-lowering therapy)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Dementia or other neuropsychiatric disorder that interferes with medication adherence&#xD;
  &#xD;
            -  CAC scan, coronary CT angiogram, or invasive angiogram since LDCT&#xD;
  &#xD;
            -  Statin medication intolerance or allergy&#xD;
  &#xD;
            -  Life expectancy &lt;2 years, e.g., metastatic cancer or active cancer undergoing&#xD;
               chemotherapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>84 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>David J Maron, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>David J Maron, MD</last_name>
      <phone>650-724-6152</phone>
      <email>david.maron@stanford.edu</email>
    </overall_contact>
    <reference>
      <citation>Sandhu AT, Rodriguez F, Ngo S, Patel BN, Mastrodicasa D, Eng D, Khandwala N, Balla S, Sousa D, Maron DJ. Incidental Coronary Artery Calcium: Opportunistic Screening of Previous Nongated Chest Computed Tomography Scans to Improve Statin Rates (NOTIFY-1 Project). Circulation. 2023 Feb 28;147(9):703-714. doi: 10.1161/CIRCULATIONAHA.122.062746. Epub 2022 Nov 7.</citation>
      <PMID>36342823</PMID>
    </reference>
    <reference>
      <citation>Eng D, Chute C, Khandwala N, Rajpurkar P, Long J, Shleifer S, Khalaf MH, Sandhu AT, Rodriguez F, Maron DJ, Seyyedi S, Marin D, Golub I, Budoff M, Kitamura F, Takahashi MS, Filice RW, Shah R, Mongan J, Kallianos K, Langlotz CP, Lungren MP, Ng AY, Patel BN. Automated coronary calcium scoring using deep learning with multicenter external validation. NPJ Digit Med. 2021 Jun 1;4(1):88. doi: 10.1038/s41746-021-00460-1.</citation>
      <PMID>34075194</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>David Maron</investigator_full_name>
      <investigator_title>Professor of Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Atherosclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977413
  org study id: 71202
  nct id: NCT05977413
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This trial will investigate whether notifying patients and their clinicians of the presence
        of moderate or severe coronary artery calcium on a low-dose CT scan performed for lung cancer
        screening results in a lower incidence of cardiovascular death, nonfatal myocardial
        infarction, or nonfatal stroke as compared with usual care informed by clinical practice
        guidelines.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
  time frame: 6 years
  measure: Rate of All-cause Death
  time frame: 6 years
  description: Number (%) of participants in each treatment group with death from any cause.
  measure: Rate of Cardiovascular Death
  time frame: 6 years
  description: Number (%) of participants in each treatment group with cardiovascular death
  measure: Rate of Nonfatal Myocardial Infarction
  time frame: 6 years
  description: Number (%) of participants in each treatment group with nonfatal myocardial infarction
  measure: Rate of Nonfatal Stroke
  time frame: 6 years
  description: Number (%) of participants in each treatment group with nonfatal stroke
  measure: Initial lipid-lowering therapy prescription rate
  time frame: within 6 months of 1st notification
  description: Number (%) of participants in each treatment group with active prescriptions of lipid-lowering therapy at 6 months following randomization
  measure: Number of Participants with active lipid-lowering therapy prescriptions
  time frame: At 18 months
  description: Persistence of need for lipid-lowering therapy at 18 months following randomization.
  measure: Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)
  time frame: 6 years
  description: Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)
  measure: Rate of Specific Statin Prescribed and Statin Dose
  time frame: 1 year post randomization
  description: Rate of prescription of specific statins at specific doses
  measure: Rate of Prescription of Non-statin Lipid-lowering Medications
  time frame: 1 year post randomization
  description: Rate of prescription of specific non-statins
  measure: Rate of Aspirin Prescription
  time frame: 1 year post randomization
  description: Rate of aspirin prescription by treatment group
  measure: Number of Antihypertensive Medications
  time frame: 1 year post randomization
  description: Number of antihypertensive medications prescribed per participant by treatment group
  measure: Median LDL-C Concentration
  time frame: 1 year post randomization
  description: Median LDL cholesterol concentration by treatment group
  measure: Percentage of participants with LDL-C <70 mg/dL
  time frame: 1 year post randomization
  description: Percentage of participants with LDL-C <70 mg/dL by treatment group
  measure: Systolic blood pressure
  time frame: 1 year post randomization
  description: Median systolic blood pressure value in mmHg by treatment group
  measure: Percentage of participants with Systolic Blood Pressure <130 mmHg
  time frame: 1 year post randomization
  description: Percentage of participants with systolic blood pressure <130 mmHg by treatment group
  measure: Body Mass Index
  time frame: 1 year post randomization
  description: Median body mass index value by treatment group
  measure: Total number of primary care clinical encounters during the trial
  time frame: 6 years
  measure: Number of cardiology encounters
  time frame: 6 years
  measure: Number of cardiovascular diagnostic noninvasive tests
  time frame: 6 years
  arm group label: Notification of CAC
  arm group type: Experimental
  description: For patients randomized to the notification of CAC arm (NC), primary clinicians will be notified that with the assistance of a deep-learning algorithm, one of their patients was found to have a CAC score >100 AU. The notification will include an image taken from the CT scan with CAC clearly marked. The notification will also include American Heart Association/American College of Cardiology 2a recommendation to initiate lipid lowering therapy (usually statin) given the presence of moderate-severe CAC.
  Patients randomized to notification will receive messages (via EHR portal-based messages, text, or US postal mail) with notification of CAC presence on their LDCT, images showing the presence of CAC from their previous chest CT clearly marked, the recommendation to discuss statin or other lipid-lowering therapy with their clinician, and a link to a patient-friendly website about CAC and risk factor control. There will be reminder messages sent at 3 weeks and 12 months.
  arm group label: Usual Care
  arm group type: Other
  description: Patients randomized to Usual Care will receive usual medical care provided by their clinician informed by widely publicized clinical practice guidelines.
  intervention type: Other
  intervention name: Notification of CAC
  description: Provider and patient are notified of coronary artery calcium present on patient's CT scan. Notification includes a personalized image of CAC from the patient's CT scan performed for lung cancer screening.
  arm group label: Notification of CAC
  intervention type: Other
  intervention name: Usual Care
  description: Patients randomized to Usual Care will receive usual medical care provided by their clinician informed by widely publicized clinical practice guidelines.
  arm group label: Usual Care
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 84 Years
  healthy volunteers: No
  last name: David J Maron, MD
  role: Principal Investigator
  affiliation: Stanford University
  last name: David J Maron, MD
  phone: 650-724-6152
  email: david.maron@stanford.edu
  citation: Sandhu AT, Rodriguez F, Ngo S, Patel BN, Mastrodicasa D, Eng D, Khandwala N, Balla S, Sousa D, Maron DJ. Incidental Coronary Artery Calcium: Opportunistic Screening of Previous Nongated Chest Computed Tomography Scans to Improve Statin Rates (NOTIFY-1 Project). Circulation. 2023 Feb 28;147(9):703-714. doi: 10.1161/CIRCULATIONAHA.122.062746. Epub 2022 Nov 7.
  PMID: 36342823
  citation: Eng D, Chute C, Khandwala N, Rajpurkar P, Long J, Shleifer S, Khalaf MH, Sandhu AT, Rodriguez F, Maron DJ, Seyyedi S, Marin D, Golub I, Budoff M, Kitamura F, Takahashi MS, Filice RW, Shah R, Mongan J, Kallianos K, Langlotz CP, Lungren MP, Ng AY, Patel BN. Automated coronary calcium scoring using deep learning with multicenter external validation. NPJ Digit Med. 2021 Jun 1;4(1):88. doi: 10.1038/s41746-021-00460-1.
  PMID: 34075194
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: David Maron
  investigator title: Professor of Medicine
  mesh term: Cardiovascular Diseases
  mesh term: Atherosclerosis
  sharing ipd: No