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Atherosclerotic Cardiovascular DiseaseICC QINCT04789278

Incidental Coronary Calcification Quality Improvement Project

A study testing Notification in people with Atherosclerotic Cardiovascular Disease and Coronary Artery Disease, run by Stanford University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Notification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
1 siteUnited States
Study dates
30 Mar 2021to 15 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford Hospital & Clinics

    Stanford, California, 94066

Other trials in United States

About this study

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.

Being tested
Notification
Keywords
Coronary Calcium, Statin, Non-gated Chest CT
Medical subject headings
Atherosclerosis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NotificationOther

    Notification of coronary calcium to the patient and their clinician

Study groups in NCT04789278
Study groupRoleWhat they receive
NotificationExperimentalPatients 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.
Receives: Other: Notification
Usual CareNo interventionBoth 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Statin Prescription

    Proportion of patients prescribed a statin

    Measured: Within 6 months

Secondary outcomes (14)

  1. Statin Intensity

    Proportion of patients prescribed a high intensity, intermediate intensity, and low intensity statin

    Measured: 6 months

  2. Total Cholesterol Level

    Measured: 6 months

  3. LDL Cholesterol Level

    Measured: 6 months

  4. HDL Cholesterol Level

    Measured: 6 months

  5. Triglyceride Level

    Measured: 6 months

  6. Systolic Blood Pressure

    Measured: 6 months

  7. Number of Hypertension Medications

    Measured: 6 months

  8. Hemoglobin A1c Level

    Measured: 6 months

  9. Body Mass Index

    Measured: 6 months

  10. Pooled cohort equations estimated 10-year risk of atherosclerotic cardiovascular disease

    Measured: 6 months

  11. Rate of Aspirin Prescription

    Proportion of patients prescribed aspirin

    Measured: 6 months

  12. Number of primary Care Clinical Encounters

    Measured: 6 months

  13. Number of Cardiology Referrals

    Measured: 6 months

  14. Number of Cardiovascular Diagnostic Tests

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2021
  2. Study start30 Mar 2021
  3. Primary completion15 Jan 2022
  4. Study completion15 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04789278
Sponsor's protocol ID
ICC-QI-2021
Acronym
ICC QI
Status last verified
Jul 2022
First submitted
26 Feb 2021
Last updated
29 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36342823

Questions about this trial

What is this clinical trial studying?

A study testing Notification in people with Atherosclerotic Cardiovascular Disease and Coronary Artery Disease, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Statin Prescription (time frame: Within 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04789278, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.

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