Atherosclerotic Cardiovascular Disease (ASCVD)HEARTWISENCT07355894
Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in ASCVD (HEARTWISE-ASCVD)
A study testing AI-Detected CAC Notification and Care Facilitation in people with Atherosclerotic Cardiovascular Disease (ASCVD) and Coronary Artery Calcification, run by Stanford University at 6 sites in United States.
Trial summary
This multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease (ASCVD), Coronary Artery Calcification
- What is being tested?
- AI-Detected CAC Notification and Care Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120,000 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-gated chest CT performed within the prior 2 years within the health system
- Active health system engagement with an affiliated clinician eligible for notification, defined as ≥1 clinical visit within the prior 2 years AND at least one of the following:
- Active enrollment in the site's integrated healthcare plan (e.g., Kaiser Permanente Northern California), OR
- LDL-C measured within the health system within the prior 2 years, OR
- Outpatient cardiovascular medication prescription within the prior year
- Meets one of the following clinical criteria:
Show all 10Show fewer
- Clinical ASCVD diagnosis (coronary artery disease, peripheral arterial disease, or ischemic cerebrovascular disease) AND AI-detected CAC >0 on non-gated chest CT, OR
- No ASCVD diagnosis AND AI-detected CAC ≥100
- Suboptimal LDL-C control, defined as either: Last LDL-C ≥70 mg/dL in the last 2 years, OR No LDL-C measurement in the last 2 years
- Note: Site-level variations and additional refinements may occur based on local stakeholder input and patient population identification.
Who cannot join
- Dementia
- Heart transplant
- Active hospice
- Other life-limiting illness as determined by the site investigator (e.g., metastatic cancer)
- Additional participant-level exclusions as determined by clinical stakeholders at each site
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Baylor Scott & White
Dallas, Texas, 95226
Duke University Medical Center
Durham, North Carolina, 27710
University of California, Los Angeles
Los Angeles, California, 90095
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Kaiser Permanente Northern California
Pleasanton, California, 94588
Stanford University
Stanford, California, 94305
About this study
Official title: Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in AtheroSclerotic CardioVascular Disease (HEARTWISE-ASCVD) Study
This multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults. The study uses artificial intelligence to detect calcium buildup in heart arteries (coronary artery calcium or CAC) on chest CT scans that patients have already had for other reasons. The study will focus on adults who either have known atherosclerotic cardiovascular disease (ASCVD) or have significant calcium buildup (a CAC score of 100 or higher), and whose cholesterol is not well controlled.
It will also evaluate how well this approach can be implemented at scale across multiple health systems. The main questions it aims to answer are:
Read more
Does notifying patients and their clinicians about incidental CAC increase lipid-lowering therapy(LLT) initiation or intensification?
Does the intervention improve Low-Density Lipoprotein(LDL)-cholesterol control and related lipid testing?
How does the intervention affect downstream care (e.g., clinic visits, cardiology referrals, and cardiac testing)?
Researchers will use an FDA-cleared AI algorithm to quantify CAC on previously performed non-gated chest CT scans and identify eligible participants through the electronic health record. Participants will be randomized to receive CAC notification either right away or after a 6-month delay.
- Being tested
- AI-Detected CAC Notification and Care Facilitation
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Detected CAC Notification and Care FacilitationOther
After randomization to the early notification arm, the study team will send a standardized notification message to the participant's affiliated clinician. The study team will send a message to the participant after a brief delay. Each site will determine the timing between the initial message to the clinician and the participant based on stakeholder feedback.
The notification is about the AI-CAC identified on the participant's previous chest CT. It will provide an overview of AI-CAC, a personalized image of AI-CAC, and a recommended risk discussion with their clinician. These clinicians will also be notified of the findings.
For participants randomized to early notification who do not undergo LLT initiation, intensification, or LDL testing within 2 months, the clinician and participant will receive a second message at that time.
The participants in the delayed notification arm will receive a similar notification 6 months later.
| Study group | Role | What they receive |
|---|---|---|
| Early Notification | Experimental | For participants randomized to notification, the affiliated clinician will receive a message notifying them of the presence of CAC. The notification will include a description of the significance of CAC, provide guideline recommendations, and include a personalized CAC image (as possible). The message will recommend having a risk discussion with the participant. Based on site-level stakeholder feedback, this alert can be retriggered at 2 months for participants who do not have LLT initiation or intensification or LDL-C testing.
Participants will also receive a notification. Based on stakeholder input, this notification can be delivered centrally or from individual clinicians. The notification will include a description of the significance of CAC, a personalized image (as possible), and recommend a risk discussion with their clinician. Receives: Other: AI-Detected CAC Notification and Care Facilitation |
| Delayed Notification | No intervention | Participants will have their CT scans interpreted and reported according to standard clinical practice. This may mention the presence of CAC in the official radiology imaging report, per usual practice. Participants will not receive any notification beyond this standard of care during the 6-month study period. The study team will send a similar notification as the early notification arm to the participants after completion of the study's primary endpoint assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid-lowering therapy initiation or intensification (LLTI)
- Number of new statin prescriptions
- Number of statin doses/intensity increase
- Number of PSCK9 inhibitor initiation (monoclonal antibodies and siRNA)
- Number of Ezetimibe initiations
- Number of Bempedoic acid initiations
Measured: 6 months after participant randomization
Secondary outcomes (5)
Aspirin prescription
Number of new Aspirin or other antiplatelet prescription
Measured: 6 months after participant randomization
Lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides) ordering
Number of Lipid panel ordering
Measured: 6 months after participant randomization
Lipoprotein(a) test ordering
Number of Lipoprotein(a) test ordering
Measured: 6 months after participant randomization
Changes of total cholesterol, HDL-C, LDL-C, triglycerides, Lipoprotein(a) levels
This outcome measure the changes of the test levels
Measured: 6 months after participant randomization
Healthcare resource use
- Number of primary care clinical encounters
- Number of cardiology encounters
- Number of coronary artery disease-related imaging tests (e.g. noninvasive stress tests, coronary computed tomography angiography (CCTAs), and angiograms)
Measured: Baseline through Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular Disease (ASCVD)Studies 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
- 120,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Baylor Scott and White Health, Kaiser Permanente, Vanderbilt University Medical Center, Duke University, University of California, Los Angeles
- Responsible party
- Principal investigator, Fatima Rodriguez, Stanford University
- Investigators
- Fatima Rodriguez, MD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355894
- Sponsor's protocol ID
- 84062
- Acronym
- HEARTWISE
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- 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
- Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in AtheroSclerotic CardioVascular Disease (HEARTWISE-ASCVD) Study
- ClinicalTrials.gov ID
- NCT07355894
- Acronym / sponsor ID
- HEARTWISE / 84062
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Amgen, Baylor Scott and White Health, Kaiser Permanente, Vanderbilt University Medical Center, Duke University, University of California, Los Angeles
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 21 Jan 2026 (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 multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults. The study uses artificial intelligence to detect calcium buildup in heart arteries (coronary artery calcium or CAC) on chest CT scans that patients have already had for other reasons. The study will focus on adults who either have known atherosclerotic cardiovascular disease (ASCVD) or have significant calcium buildup (a CAC score of 100 or higher), and whose cholesterol is not well controlled.
It will also evaluate how well this approach can be implemented at scale across multiple health systems. The main questions it aims to answer are:
Does notifying patients and their clinicians about incidental CAC increase lipid-lowering therapy(LLT) initiation or intensification?
Does the intervention improve Low-Density Lipoprotein(LDL)-cholesterol control and related lipid testing?
How does the intervention affect downstream care (e.g., clinic visits, cardiology referrals, and cardiac testing)?
Researchers will use an FDA-cleared AI algorithm to quantify CAC on previously performed non-gated chest CT scans and identify eligible participants through the electronic health record. Participants will be randomized to receive CAC notification either right away or after a 6-month delay.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Notification | Experimental | Other: AI-Detected CAC Notification and Care FacilitationFor participants randomized to notification, the affiliated clinician will receive a message notifying them of the presence of CAC. The notification will include a description of the significance of CAC, provide guideline recommendations, and include a personalized CAC image (as possible). The message will recommend having a risk discussion with the participant. Based on site-level stakeholder feedback, this alert can be retriggered at 2 months for participants who do not have LLT initiation or intensification or LDL-C testing. Participants will also receive a notification. Based on stakeholder input, this notification can be delivered centrally or from individual clinicians. The notification will include a description of the significance of CAC, a personalized image (as possible), and recommend a risk discussion with their clinician. |
| Delayed Notification | No intervention | –Participants will have their CT scans interpreted and reported according to standard clinical practice. This may mention the presence of CAC in the official radiology imaging report, per usual practice. Participants will not receive any notification beyond this standard of care during the 6-month study period. The study team will send a similar notification as the early notification arm to the participants after completion of the study's primary endpoint assessment. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Non-gated chest CT performed within the prior 2 years within the health system
- Active health system engagement with an affiliated clinician eligible for notification, defined as ≥1 clinical visit within the prior 2 years AND at least one of the following:
- Meets one of the following clinical criteria:
- Suboptimal LDL-C control, defined as either: Last LDL-C ≥70 mg/dL in the last 2 years, OR No LDL-C measurement in the last 2 years
- Note: Site-level variations and additional refinements may occur based on local stakeholder input and patient population identification.
Key exclusion criteria (5 listed)
- Dementia
- Heart transplant
- Active hospice
- Other life-limiting illness as determined by the site investigator (e.g., metastatic cancer)
- Additional participant-level exclusions as determined by clinical stakeholders at each site
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 |
|---|---|---|
| AI-Detected CAC Notification and Care FacilitationAfter randomization to the early notification arm, the study team will send a standardized notification message to the participant's affiliated clinician. The study team will send a message to the participant after a brief delay. Each site will determine the timing between the initial message to the clinician and the participant based on stakeholder feedback. The notification is about the AI-CAC identified on the participant's previous chest CT. It will provide an overview of AI-CAC, a personalized image of AI-CAC, and a recommended risk discussion with their clinician. These clinicians will also be notified of the findings. For participants randomized to early notification who do not undergo LLT initiation, intensification, or LDL testing within 2 months, the clinician and participant will receive a second message at that time. The participants in the delayed notification arm will receive a similar notification 6 months later. | Other | Early Notification |
Primary outcome
Lipid-lowering therapy initiation or intensification (LLTI)
Time frame: 6 months after participant randomization
* Number of new statin prescriptions * Number of statin doses/intensity increase * Number of PSCK9 inhibitor initiation (monoclonal antibodies and siRNA) * Number of Ezetimibe initiations * Number of Bempedoic acid initiations
5 secondary outcomes
Aspirin prescription
Time frame: 6 months after participant randomization
Lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides) ordering
Time frame: 6 months after participant randomization
Lipoprotein(a) test ordering
Time frame: 6 months after participant randomization
Changes of total cholesterol, HDL-C, LDL-C, triglycerides, Lipoprotein(a) levels
Time frame: 6 months after participant randomization
Healthcare resource use
Time frame: Baseline through Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Fatima Rodriguez, MD, MPH principal investigator
Stanford University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Detected CAC Notification and Care Facilitation in people with Atherosclerotic Cardiovascular Disease (ASCVD) and Coronary Artery Calcification, run by Stanford University at 6 sites 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: opening soon, 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 6 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Lipid-lowering therapy initiation or intensification (LLTI) (time frame: 6 months after participant randomization). 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; AzTrials last refreshed its copy on 5 Nov 2026.