Coronary Artery DiseaseNCT05394181
Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates
A study testing Notification in people with Coronary Artery Disease, run by Stanford University at 1 site in United States.
Trial summary
The primary objective is to estimate the impact of notification of primary care provider and patient of at least moderate incidental coronary artery calcification (CAC) on a prior non-gated chest CT on statin prescription rates at 4 months among patients without a clinical history of atherosclerotic cardiovascular… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Notification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 15 Mar 2023
- 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
- Age greater than or equal to 18 and less than 85
- Non-gated chest CT from 1/1/2016-6/30/2020 with algorithm screening estimating CAC score of at least 100 Agatston Units with radiologist confirmation of moderate or severe CAC
- Encounter with Palo Alto VA affiliated primary care since 2020
Who cannot join
- Prior diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
- Dementia
- Metastatic cancer or active cancer undergoing chemotherapy
- CT coronary angiogram since 2016
- Invasive Coronary angiogram since 2016
- CAC scan since 2016
Show all 13Show fewer
- Statin therapy within prior 6 months
- Prior ezetimibe or PCSK9 inhibitor therapy
- Prior rhabdomyolysis with statin therapy
- Schizophrenia
- Substance abuse disorder (alcohol, amphetamines, cocaine, opioids)
- Hospice
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Veteran's Affairs Hospital
Palo Alto, California, 94304
About this study
The primary objective is to estimate the impact of notification of primary care provider and patient of at least moderate incidental coronary artery calcification (CAC) on a prior non-gated chest CT on statin prescription rates at 4 months among patients without a clinical history of atherosclerotic cardiovascular disease not actively on statin therapy. This study will determine if notifying patients and their primary care clinician about an existing finding will influence shared decision-making around statins between patients and their primary care clinician.
- Conditions
- Coronary Artery Disease
- Being tested
- Notification
- Medical subject headings
- 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 patient and primary care clinician of presence of at least moderate coronary artery calcium on a prior non-gated chest CT
| Study group | Role | What they receive |
|---|---|---|
| Notification | Experimental | Notification of the presence of at least moderate coronary artery calcium on a prior non-gated chest CT Receives: Other: Notification |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin prescription rate
Prescription of statin medication
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Aug 2022 (estimated)
- Primary completion15 Jan 2023 (estimated)
- Study completion15 Mar 2023 (estimated)
Why it stopped: Change in resource allocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394181
- Sponsor's protocol ID
- 64798
- Status last verified
- Feb 2026
- First submitted
- 24 May 2022
- Last updated
- 27 Feb 2026
- Results posted
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates
- ClinicalTrials.gov ID
- NCT05394181
- Acronym / sponsor ID
- 64798
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in resource allocation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 27 May 2022 (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.
The primary objective is to estimate the impact of notification of primary care provider and patient of at least moderate incidental coronary artery calcification (CAC) on a prior non-gated chest CT on statin prescription rates at 4 months among patients without a clinical history of atherosclerotic cardiovascular disease not actively on statin therapy. This study will determine if notifying patients and their primary care clinician about an existing finding will influence shared decision-making around statins between patients and their primary care clinician.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Notification | Experimental | Other: NotificationNotification of the presence of at least moderate coronary artery calcium on a prior non-gated chest CT |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 and less than 85
- Non-gated chest CT from 1/1/2016-6/30/2020 with algorithm screening estimating CAC score of at least 100 Agatston Units with radiologist confirmation of moderate or severe CAC
- Encounter with Palo Alto VA affiliated primary care since 2020
Key exclusion criteria (13 listed)
- Prior diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
- Dementia
- Metastatic cancer or active cancer undergoing chemotherapy
- CT coronary angiogram since 2016
- Invasive Coronary angiogram since 2016
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 |
|---|---|---|
| NotificationNotification of patient and primary care clinician of presence of at least moderate coronary artery calcium on a prior non-gated chest CT | Other | Notification |
Primary outcome
Statin prescription rate
Time frame: 4 months
Prescription of statin medication
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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 in people with 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 13 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: withdrawn, as of the sponsor's last update on 27 Feb 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 was withdrawn before enrolling participants, so there are no results.
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?
Statin prescription rate (time frame: 4 months). 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 27 Feb 2026.