Atherosclerotic Cardiovascular DiseaseNOTIFYNCT05977413
NOTIFY (New Observations Taking Information From Yesterday)
A study testing CAC Notification and Clinician Guideline Reminder in people with Atherosclerotic Cardiovascular Disease, run by Stanford University.
Trial summary
This trial will investigate whether notifying patients and their clinicians of the presence of moderate or severe coronary artery calcium on a low-dose CT scan performed for lung cancer screening results in a lower incidence of death, nonfatal myocardial infarction, or nonfatal stroke as compared with practice… Read more about this study
- Who is it for?
- Ages 50 to 84 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- CAC Notification and Clinician Guideline Reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to Jun 2032
- 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 50 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years
- No known ASCVD
- Lung cancer screenee with low dose CT scan (LDCT) within the last 5 years
- Coronary artery calcium (CAC) score on LDCT >100 Agatston units (AU)
- Not taking a statin or other lipid-lowering therapy (e.g., ezetimibe, bempedoic acid, or PCSK9-lowering therapy)
Who cannot join
- Dementia or other neuropsychiatric disorder that interferes with medication adherence
- CAC scan, coronary CT angiogram, or invasive angiogram since LDCT
- Statin medication intolerance or allergy
- Life expectancy <2 years, e.g., metastatic cancer or active cancer undergoing chemotherapy
About this study
Official title: NOTIFY-OUTCOMES (New Observations Taking Information From Yesterday)
This trial will investigate whether notifying patients and their clinicians of the presence of moderate or severe coronary artery calcium on a low-dose CT scan performed for lung cancer screening results in a lower incidence of death, nonfatal myocardial infarction, or nonfatal stroke as compared with practice guideline reminders.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- CAC Notification, Clinician Guideline Reminder
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAC NotificationOther
Patient-Clinician CAC Notification. The CAC Notification intervention sent to both patients and clinicians has five features. 1) Results of a high CAC score (>100 AU) detected on the patient's prior chest CT, 2) an image of the patient's CAC clearly marked, 3) a recommendation to have a patient-clinician risk discussion, 4) specific statin dosing recommended by guidelines, and 5) a link to the prevention gidelines.
Clinician Guideline ReminderOther
The Guideline Reminder intervention sent to primary care clinicians has five features. 1) A reminder that all patients should have their 10-year risk for ASCVD events calculated, 2) a figure of the recommended treatment algorithm according to ASCVD 10-year risk, 3) a nudge that patients who qualify for lung cancer screening are generally at high ASCVD risk, 4) a reminder that patients at elevated risk should be engaged in shared decision-making to discuss statin therapy and other preventive interventions, and 5) access to the complete ACC/AHA Primary Prevention Guidelines and the online 10-year ASCVD risk estimator.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Clinician CAC Notification | Experimental | The CAC Notification intervention sent to both patients and clinicians has five features. 1) Results of a high CAC score (>100 AU) detected on the patient's prior chest CT, 2) an image of the patient's CAC clearly marked, 3) a recommendation to have a patient-clinician risk discussion, 4) specific statin dosing recommended by guidelines, and 5) a link to the prevention gidelines. Receives: Other: CAC Notification |
| Clinician Guideline Reminder | Other | The Guideline Reminder intervention sent to primary care clinicians has five features. 1) A reminder that all patients should have their 10-year risk for ASCVD events calculated, 2) a figure of the recommended treatment algorithm according to ASCVD 10-year risk, 3) a nudge that patients who qualify for lung cancer screening are generally at high ASCVD risk, 4) a reminder that patients at elevated risk should be engaged in shared decision-making to discuss statin therapy and other preventive interventions, and 5) access to the complete ACC/AHA Primary Prevention Guidelines and the online 10-year ASCVD risk estimator. Receives: Other: Clinician Guideline Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke
Measured: 6 years
Secondary outcomes (7)
Rate of All-cause Death
Number (%) of participants in each treatment group with death from any cause.
Measured: 6 years
Rate of Cardiovascular Death
Number (%) of participants in each treatment group with cardiovascular death
Measured: 6 years
Rate of Nonfatal Myocardial Infarction
Number (%) of participants in each treatment group with nonfatal myocardial infarction
Measured: 6 years
Rate of Nonfatal Stroke
Number (%) of participants in each treatment group with nonfatal stroke
Measured: 6 years
Initial lipid-lowering therapy prescription rate
Number (%) of participants in each treatment group with active prescriptions of lipid-lowering therapy at 6 months following randomization
Measured: within 6 months of 1st notification
Number of Participants with active lipid-lowering therapy prescriptions
Persistence of need for lipid-lowering therapy at 18 months following randomization.
Measured: At 18 months
Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)
Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Mar 2026 (estimated)
- Primary completionJun 2032 (estimated)
- Study completionJun 2032 (estimated)
Why it stopped: The trial was never started because it was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Cardiovascular 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Maron, Stanford University
- Investigators
- David J Maron, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977413
- Sponsor's protocol ID
- 71202
- Acronym
- NOTIFY
- Status last verified
- Feb 2026
- First submitted
- 19 Jul 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 36342823Eng D, Chute C, Khandwala N, Rajpurkar P, Long J, Shleifer S, Khalaf MH, Sandhu AT, Rodriguez F, Maron DJ, Seyyedi S, Marin D, Golub I, Budoff M, Kitamura F, Takahashi MS, Filice RW, Shah R, Mongan J, Kallianos K, Langlotz CP, Lungren MP, Ng AY, Patel BN. Automated coronary calcium scoring using deep learning with multicenter external validation. NPJ Digit Med. 2021 Jun 1;4(1):88. doi: 10.1038/s41746-021-00460-1.
PubMed 34075194
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOTIFY-OUTCOMES (New Observations Taking Information From Yesterday)
- ClinicalTrials.gov ID
- NCT05977413
- Acronym / sponsor ID
- NOTIFY / 71202
- Conditions
- Atherosclerotic Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial was never started because it was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 4 Aug 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.
This trial will investigate whether notifying patients and their clinicians of the presence of moderate or severe coronary artery calcium on a low-dose CT scan performed for lung cancer screening results in a lower incidence of death, nonfatal myocardial infarction, or nonfatal stroke as compared with practice guideline reminders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-Clinician CAC Notification | Experimental | Other: CAC NotificationThe CAC Notification intervention sent to both patients and clinicians has five features. 1) Results of a high CAC score (>100 AU) detected on the patient's prior chest CT, 2) an image of the patient's CAC clearly marked, 3) a recommendation to have a patient-clinician risk discussion, 4) specific statin dosing recommended by guidelines, and 5) a link to the prevention gidelines. |
| Clinician Guideline Reminder | Other | Other: Clinician Guideline ReminderThe Guideline Reminder intervention sent to primary care clinicians has five features. 1) A reminder that all patients should have their 10-year risk for ASCVD events calculated, 2) a figure of the recommended treatment algorithm according to ASCVD 10-year risk, 3) a nudge that patients who qualify for lung cancer screening are generally at high ASCVD risk, 4) a reminder that patients at elevated risk should be engaged in shared decision-making to discuss statin therapy and other preventive interventions, and 5) access to the complete ACC/AHA Primary Prevention Guidelines and the online 10-year ASCVD risk estimator. |
Who may qualify
- Ages
- 50 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=18 years
- No known ASCVD
- Lung cancer screenee with low dose CT scan (LDCT) within the last 5 years
- Coronary artery calcium (CAC) score on LDCT >100 Agatston units (AU)
- Not taking a statin or other lipid-lowering therapy (e.g., ezetimibe, bempedoic acid, or PCSK9-lowering therapy)
Key exclusion criteria (4 listed)
- Dementia or other neuropsychiatric disorder that interferes with medication adherence
- CAC scan, coronary CT angiogram, or invasive angiogram since LDCT
- Statin medication intolerance or allergy
- Life expectancy <2 years, e.g., metastatic cancer or active cancer undergoing chemotherapy
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 |
|---|---|---|
| CAC NotificationPatient-Clinician CAC Notification. The CAC Notification intervention sent to both patients and clinicians has five features. 1) Results of a high CAC score (>100 AU) detected on the patient's prior chest CT, 2) an image of the patient's CAC clearly marked, 3) a recommendation to have a patient-clinician risk discussion, 4) specific statin dosing recommended by guidelines, and 5) a link to the prevention gidelines. | Other | Patient-Clinician CAC Notification |
| Clinician Guideline ReminderThe Guideline Reminder intervention sent to primary care clinicians has five features. 1) A reminder that all patients should have their 10-year risk for ASCVD events calculated, 2) a figure of the recommended treatment algorithm according to ASCVD 10-year risk, 3) a nudge that patients who qualify for lung cancer screening are generally at high ASCVD risk, 4) a reminder that patients at elevated risk should be engaged in shared decision-making to discuss statin therapy and other preventive interventions, and 5) access to the complete ACC/AHA Primary Prevention Guidelines and the online 10-year ASCVD risk estimator. | Other | Clinician Guideline Reminder |
Primary outcome
Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke
Time frame: 6 years
7 secondary outcomes
Rate of All-cause Death
Time frame: 6 years
Rate of Cardiovascular Death
Time frame: 6 years
Rate of Nonfatal Myocardial Infarction
Time frame: 6 years
Rate of Nonfatal Stroke
Time frame: 6 years
Initial lipid-lowering therapy prescription rate
Time frame: within 6 months of 1st notification
Number of Participants with active lipid-lowering therapy prescriptions
Time frame: At 18 months
Number of revascularization procedures (PCI, CABG, carotid artery revascularization, or peripheral artery revascularization)
Time frame: 6 years
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 10 Feb 2026.
- Background: PubMed 36342823Sandhu 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.
- Background: PubMed 34075194Eng D, Chute C, Khandwala N, Rajpurkar P, Long J, Shleifer S, Khalaf MH, Sandhu AT, Rodriguez F, Maron DJ, Seyyedi S, Marin D, Golub I, Budoff M, Kitamura F, Takahashi MS, Filice RW, Shah R, Mongan J, Kallianos K, Langlotz CP, Lungren MP, Ng AY, Patel BN. Automated coronary calcium scoring using deep learning with multicenter external validation. NPJ Digit Med. 2021 Jun 1;4(1):88. doi: 10.1038/s41746-021-00460-1.
- Individual participant dataSharing planned: No
Related trials for Atherosclerotic Cardiovascular Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Active, not recruiting
SELUTION4SFA Trial
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingEarly Phase 1
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
Oligometastatic Disease
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
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.
David J Maron, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing CAC Notification and Clinician Guideline Reminder in people with Atherosclerotic Cardiovascular Disease, run by Stanford University.
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 5 inclusion and 4 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Time to first occurrence of death, nonfatal myocardial infarction, or nonfatal stroke (time frame: 6 years). 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 NCT05977413, which also lists 2 linked publications.
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 10 Feb 2026.