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Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD) (NOTIFY-ASCVD)

Primary Purpose

ASCVD, Coronary Artery Calcification

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Notification of patients and clinicians
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ASCVD

Eligibility Criteria

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

Inclusion Criteria: Presence of CAC on non-gated chest CT scans performed from 2014 to 2022 Age <85 years Diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease Visit to Stanford affiliated clinician since 2020 at one of the following Stanford clinics including University affiliated clinics: Internal Medicine Family Medicine Cardiology Neurology Vascular surgery Exclusion Criteria: Dementia Metastatic cancer or active cancer undergoing chemotherapy Patients on high-intensity statin therapy with LDL-C <70 mg/dL Patients receiving treatment with a PCSK9-lowering therapy (alirocumab, evolocumab, or inclisiran)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Notification with a CAC image

    Notification without a CAC image

    Usual care

    Arm Description

    Notification of presence of CAC with a CT scan image

    Notification of presence of CAC without a CT scan image

    Usual care

    Outcomes

    Primary Outcome Measures

    Initiation or intensification of lipid-lowering therapy
    Number of patients who had initiation or intensification of lipid-lowering therapy

    Secondary Outcome Measures

    Full Information

    First Posted
    May 5, 2023
    Last Updated
    May 5, 2023
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05858879
    Brief Title
    Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)
    Acronym
    NOTIFY-ASCVD
    Official Title
    Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a randomized QI project evaluating the impact of notifying both patients and their clinicians of presence of incidental coronary artery calcium (CAC) on initiation or intensification of lipid-lowering therapy in patients with ASCVD who are not receiving guideline-directed lipid-lowering therapy or have LDL cholesterol (LDL-C) ≥70 mg/dL.
    Detailed Description
    This is a randomized qualify improvement (QI) project evaluating the impact of notifying patients and their clinicians of incidental CAC detected on a prior chest CT scan. Patients will be identified by screening previous non-gated chest CT scans and electronic health records. The presence of CAC will be confirmed by a radiologist. Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ASCVD, Coronary Artery Calcification

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.
    Masking
    ParticipantCare Provider
    Masking Description
    In the usual care arm, patients or clinicians will not be notified.
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Notification with a CAC image
    Arm Type
    Active Comparator
    Arm Description
    Notification of presence of CAC with a CT scan image
    Arm Title
    Notification without a CAC image
    Arm Type
    Active Comparator
    Arm Description
    Notification of presence of CAC without a CT scan image
    Arm Title
    Usual care
    Arm Type
    Placebo Comparator
    Arm Description
    Usual care
    Intervention Type
    Other
    Intervention Name(s)
    Notification of patients and clinicians
    Intervention Description
    Notification Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or US mail that will inform them of the CAC identified on their previous chest CT scan and a recommendation that they discuss this finding and initiation or intensification of lipid-lowering therapy with their clinician. The clinicians will be notified of these findings by an earlier EHR message that will be sent 2 weeks before the patient notification. Usual Care The usual care arm will not receive any additional notification beyond this standard of care.
    Primary Outcome Measure Information:
    Title
    Initiation or intensification of lipid-lowering therapy
    Description
    Number of patients who had initiation or intensification of lipid-lowering therapy
    Time Frame
    Month 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    84 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Presence of CAC on non-gated chest CT scans performed from 2014 to 2022 Age <85 years Diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease Visit to Stanford affiliated clinician since 2020 at one of the following Stanford clinics including University affiliated clinics: Internal Medicine Family Medicine Cardiology Neurology Vascular surgery Exclusion Criteria: Dementia Metastatic cancer or active cancer undergoing chemotherapy Patients on high-intensity statin therapy with LDL-C <70 mg/dL Patients receiving treatment with a PCSK9-lowering therapy (alirocumab, evolocumab, or inclisiran)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fahim Abbasi, MD
    Phone
    650-624-0954
    Email
    fahim@stanford.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarah Magee
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fatima Rodriguez, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)

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