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NOTIFY (New Observations Taking Information From Yesterday) (NOTIFY)

Primary Purpose

Atherosclerotic Cardiovascular Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Notification of CAC
Usual Care
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerotic Cardiovascular Disease

Eligibility Criteria

50 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 50-84 years No known ASCVD Lung cancer screenee with low dose CT scan (LDCT) within the last 5 years Coronary artery calcium (CAC) score on LDCT >100 Agatston units (AU) Not taking a statin or other lipid-lowering therapy (e.g., ezetimibe, bempedoic acid, or PCSK9-lowering therapy) Exclusion Criteria: Dementia or other neuropsychiatric disorder that interferes with medication adherence CAC scan, coronary CT angiogram, or invasive angiogram since LDCT Statin medication intolerance or allergy Life expectancy <2 years, e.g., metastatic cancer or active cancer undergoing chemotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Notification of CAC

    Usual Care

    Arm 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.

    Patients randomized to Usual Care will receive usual medical care provided by their clinician informed by widely publicized clinical practice guidelines.

    Outcomes

    Primary Outcome Measures

    Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke

    Secondary Outcome Measures

    Rate of All-cause Death
    Number (%) of participants in each treatment group with death from any cause.
    Rate of Cardiovascular Death
    Number (%) of participants in each treatment group with cardiovascular death
    Rate of Nonfatal Myocardial Infarction
    Number (%) of participants in each treatment group with nonfatal myocardial infarction
    Rate of Nonfatal Stroke
    Number (%) of participants in each treatment group with nonfatal stroke
    Initial lipid-lowering therapy prescription rate
    Number (%) of participants in each treatment group with active prescriptions of lipid-lowering therapy at 6 months following randomization
    Number of Participants with active lipid-lowering therapy prescriptions
    Persistence of need for lipid-lowering therapy at 18 months following randomization.
    Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)
    Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)

    Full Information

    First Posted
    July 19, 2023
    Last Updated
    July 28, 2023
    Sponsor
    Stanford University
    Collaborators
    Duke University, Patient-Centered Outcomes Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05977413
    Brief Title
    NOTIFY (New Observations Taking Information From Yesterday)
    Acronym
    NOTIFY
    Official Title
    NOTIFY (New Observations Taking Information From Yesterday)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2024 (Anticipated)
    Primary Completion Date
    June 2030 (Anticipated)
    Study Completion Date
    June 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University
    Collaborators
    Duke University, Patient-Centered Outcomes Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atherosclerotic Cardiovascular Disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Notification of CAC
    Arm Type
    Experimental
    Arm 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 Title
    Usual Care
    Arm Type
    Other
    Arm 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(s)
    Notification of CAC
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Usual Care
    Intervention Description
    Patients randomized to Usual Care will receive usual medical care provided by their clinician informed by widely publicized clinical practice guidelines.
    Primary Outcome Measure Information:
    Title
    Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
    Time Frame
    6 years
    Secondary Outcome Measure Information:
    Title
    Rate of All-cause Death
    Description
    Number (%) of participants in each treatment group with death from any cause.
    Time Frame
    6 years
    Title
    Rate of Cardiovascular Death
    Description
    Number (%) of participants in each treatment group with cardiovascular death
    Time Frame
    6 years
    Title
    Rate of Nonfatal Myocardial Infarction
    Description
    Number (%) of participants in each treatment group with nonfatal myocardial infarction
    Time Frame
    6 years
    Title
    Rate of Nonfatal Stroke
    Description
    Number (%) of participants in each treatment group with nonfatal stroke
    Time Frame
    6 years
    Title
    Initial lipid-lowering therapy prescription rate
    Description
    Number (%) of participants in each treatment group with active prescriptions of lipid-lowering therapy at 6 months following randomization
    Time Frame
    within 6 months of 1st notification
    Title
    Number of Participants with active lipid-lowering therapy prescriptions
    Description
    Persistence of need for lipid-lowering therapy at 18 months following randomization.
    Time Frame
    At 18 months
    Title
    Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)
    Description
    Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)
    Time Frame
    6 years
    Other Pre-specified Outcome Measures:
    Title
    Rate of Specific Statin Prescribed and Statin Dose
    Description
    Rate of prescription of specific statins at specific doses
    Time Frame
    1 year post randomization
    Title
    Rate of Prescription of Non-statin Lipid-lowering Medications
    Description
    Rate of prescription of specific non-statins
    Time Frame
    1 year post randomization
    Title
    Rate of Aspirin Prescription
    Description
    Rate of aspirin prescription by treatment group
    Time Frame
    1 year post randomization
    Title
    Number of Antihypertensive Medications
    Description
    Number of antihypertensive medications prescribed per participant by treatment group
    Time Frame
    1 year post randomization
    Title
    Median LDL-C Concentration
    Description
    Median LDL cholesterol concentration by treatment group
    Time Frame
    1 year post randomization
    Title
    Percentage of participants with LDL-C <70 mg/dL
    Description
    Percentage of participants with LDL-C <70 mg/dL by treatment group
    Time Frame
    1 year post randomization
    Title
    Systolic blood pressure
    Description
    Median systolic blood pressure value in mmHg by treatment group
    Time Frame
    1 year post randomization
    Title
    Percentage of participants with Systolic Blood Pressure <130 mmHg
    Description
    Percentage of participants with systolic blood pressure <130 mmHg by treatment group
    Time Frame
    1 year post randomization
    Title
    Body Mass Index
    Description
    Median body mass index value by treatment group
    Time Frame
    1 year post randomization
    Title
    Total number of primary care clinical encounters during the trial
    Time Frame
    6 years
    Title
    Number of cardiology encounters
    Time Frame
    6 years
    Title
    Number of cardiovascular diagnostic noninvasive tests
    Time Frame
    6 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    84 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 50-84 years No known ASCVD Lung cancer screenee with low dose CT scan (LDCT) within the last 5 years Coronary artery calcium (CAC) score on LDCT >100 Agatston units (AU) Not taking a statin or other lipid-lowering therapy (e.g., ezetimibe, bempedoic acid, or PCSK9-lowering therapy) Exclusion Criteria: Dementia or other neuropsychiatric disorder that interferes with medication adherence CAC scan, coronary CT angiogram, or invasive angiogram since LDCT Statin medication intolerance or allergy Life expectancy <2 years, e.g., metastatic cancer or active cancer undergoing chemotherapy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David J Maron, MD
    Phone
    650-724-6152
    Email
    david.maron@stanford.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David J Maron, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    36342823
    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.
    Results Reference
    background
    PubMed Identifier
    34075194
    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.
    Results Reference
    background

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