NCT04789278

Brief Summary

This is a multi-center, randomized quality improvement project. At least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (CAC) on a prior non-gated chest CT will be enrolled across the Stanford Healthcare System and the Palo Alto Veteran's Affairs Healthcare System. Patients will be randomized in a 1:1 fashion to notification or usual care arms. The primary aim of this project is to estimate the increase in 6-month statin prescription among statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental CAC on a non-gated chest CT who are randomized to receive notification of their findings vs. usual care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

February 26, 2021

Last Update Submit

July 26, 2022

Conditions

Atherosclerotic Cardiovascular DiseaseCoronary Artery Disease

Keywords

Coronary CalciumStatinNon-gated Chest CT

Outcome Measures

Primary Outcomes (1)

  • Rate of Statin Prescription

    Proportion of patients prescribed a statin

    Within 6 months

Secondary Outcomes (14)

  • Statin Intensity

    6 months

  • Total Cholesterol Level

    6 months

  • LDL Cholesterol Level

    6 months

  • HDL Cholesterol Level

    6 months

  • Triglyceride Level

    6 months

  • +9 more secondary outcomes

Study Arms (2)

Notification

EXPERIMENTAL

Patients randomized to notification will receive a message sent by either the electronic health record (EHR) patient portal or postal mail that will inform them of the CAC identified on their previous chest CT. It will provide an overview of CAC, an image of their chest CT, and a recommendation that they discuss this finding with their clinician. These clinicians will be notified of these findings via an earlier EHR message. Any treatment decisions will be made by the patient and their clinician. Patients randomized to notification who are not prescribed a statin medication and do not have a documented discussion regarding statin therapy within three months will be sent a second message at that time. Their primary care providers will receive a second EHR message concurrently.

Other: Notification

Usual Care

NO INTERVENTION

Both arms have previously had their CT scans reported according to standard clinical practice. This may include notification of the CAC in the imaging report. The usual care arm will not receive any additional notification beyond this standard of care during the project.

Interventions

NotificationOTHER

Notification of coronary calcium to the patient and their clinician

Notification

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-gated chest CT between 2014-2019
  • The presence of CAC confirmed by manual review by an experienced radiologist
  • Stanford affiliated primary care provider or endocrinologist for Stanford healthcare system patients and VA primary care provider for VA patients with at least 1 encounter since 2018

You may not qualify if:

  • Current or prior statin or PCSK9 inhibitor therapy
  • Prior diagnosis of ASCVD (coronary artery disease, peripheral arterial disease, cerebrovascular disease, coronary/peripheral revascularization)
  • Prior coronary imaging (cardiac CT, invasive coronary angiography)
  • Dementia
  • Metastatic cancer or active cancer undergoing chemotherapy
  • History of medical nonadherence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital & Clinics

Stanford, California, 94066, United States

Location

Related Publications (1)

  • 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: 36342823DERIVED

MeSH Terms

Conditions

AtherosclerosisCoronary Artery Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart Diseases

Study Officials

  • Alexander T Sandhu, MD, MS

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Instructor of Medicine, Division of Cardiology

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 9, 2021

Study Start

March 30, 2021

Primary Completion

January 15, 2022

Study Completion

September 15, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Locations

US(1)