ASCVDNOTIFY-ASCVDNCT05858879
Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)
A study testing Notification of patients and clinicians in people with ASCVD and Coronary Artery Calcification, run by Stanford University at 1 site in United States.
Trial summary
Estimate the impact of notifying both patients and their clinicians of the presence of incidental coronary artery calcium (CAC) on initiation of lipid-lowering therapy in patients with ASCVD who are not receiving lipid-lowering therapy. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- ASCVD, Coronary Artery Calcification
- What is being tested?
- Notification of patients and clinicians
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2024to 24 Mar 2026
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of CAC on non-gated chest CT scans performed from 2021 to 2025
- Age <85 years
- Diagnosis of ASCVD(coronary artery disease, peripheral artery disease, or cerebrovascular disease)
- Visit to Stanford affiliated clinician since 2022 at one of the following Stanford clinics including University affiliated clinics:
- Internal Medicine
- Family Medicine
Show all 10Show fewer
- Cardiology
- Neurology
- Vascular surgery
- Primary language is English or Spanish
Who cannot join
- No diagnosis of ASCVD
- Patients receiving lipid-lowering therapy
- Dementia
- Metastatic cancer or active cancer undergoing chemotherapy
- Hospice
Trial locations and contacts
1 site in 1 country.
About this study
Estimate the impact of notifying both patients and their clinicians of the presence of incidental coronary artery calcium (CAC) on initiation of lipid-lowering therapy in patients with ASCVD who are not receiving lipid-lowering therapy.
Read the detailed description
This is a randomized quality improvement (QI) project evaluating the impact of notifying patients and their clinicians (primary care, cardiologists, neurologists, or vascular surgeon) 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.
- Conditions
- ASCVD, Coronary Artery Calcification
- Being tested
- Notification of patients and clinicians
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Notification of patients and cliniciansOther
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 (with or without an image) and a recommendation that they discuss this finding and initiation 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.
Two months after the initial notification, patients and their clinicians who are randomized to notification arms will receive a second message similar to the initial notification.
| Study group | Role | What they receive |
|---|---|---|
| Notification with a CAC image | Experimental | Notification of presence of CAC with a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy. Receives: Other: Notification of patients and clinicians |
| Notification without a CAC image | Experimental | Notification of presence of CAC without a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy. Receives: Other: Notification of patients and clinicians |
| Usual care | No intervention | The usual care arm will not receive any additional notification beyond the standard of care. If the intervention is successful, we will notify patients in the usual care arm of the presence of CAC and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of lipid-lowering therapy
Number of patients who had initiation of lipid-lowering therapy
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start22 Oct 2024
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASCVDStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Rodriguez, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858879
- Sponsor's protocol ID
- 70362
- Acronym
- NOTIFY-ASCVD
- Status last verified
- Apr 2026
- First submitted
- 5 May 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)
- ClinicalTrials.gov ID
- NCT05858879
- Acronym / sponsor ID
- NOTIFY-ASCVD / 70362
- Conditions
- ASCVD, Coronary Artery Calcification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Estimate the impact of notifying both patients and their clinicians of the presence of incidental coronary artery calcium (CAC) on initiation of lipid-lowering therapy in patients with ASCVD who are not receiving lipid-lowering therapy.
Detailed description
This is a randomized quality improvement (QI) project evaluating the impact of notifying patients and their clinicians (primary care, cardiologists, neurologists, or vascular surgeon) 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Notification with a CAC image | Experimental | Other: Notification of patients and cliniciansNotification of presence of CAC with a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy. |
| Notification without a CAC image | Experimental | Other: Notification of patients and cliniciansNotification of presence of CAC without a CT scan image and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy. |
| Usual care | No intervention | –The usual care arm will not receive any additional notification beyond the standard of care. If the intervention is successful, we will notify patients in the usual care arm of the presence of CAC and the ACC/AHA guideline recommendation for initiation of lipid-lowering therapy. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Presence of CAC on non-gated chest CT scans performed from 2021 to 2025
- Age <85 years
- Diagnosis of ASCVD(coronary artery disease, peripheral artery disease, or cerebrovascular disease)
- Visit to Stanford affiliated clinician since 2022 at one of the following Stanford clinics including University affiliated clinics:
- Primary language is English or Spanish
Key exclusion criteria (5 listed)
- No diagnosis of ASCVD
- Patients receiving lipid-lowering therapy
- Dementia
- Metastatic cancer or active cancer undergoing chemotherapy
- Hospice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Notification of patients and cliniciansNotification 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 (with or without an image) and a recommendation that they discuss this finding and initiation 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. Two months after the initial notification, patients and their clinicians who are randomized to notification arms will receive a second message similar to the initial notification. | Other | Notification with a CAC image, Notification without a CAC image |
Primary outcome
Initiation of lipid-lowering therapy
Time frame: Month 6
Number of patients who had initiation of lipid-lowering therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Notification of patients and clinicians in people with ASCVD and Coronary Artery Calcification, 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 22 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Initiation of lipid-lowering therapy (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.