Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in ASCVD (HEARTWISE-ASCVD) (HEARTWISE)
Hälsostärkande Artärriskuppföljning med Omfattande Implementering och Screeninginsats vid Atherosklerotisk Kardiovaskulär Sjukdom (HEARTWISE-ASCVD)-studien
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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90095
- University of California, Los Angeles
-
Pleasanton, California, Förenta staterna, 94588
- Kaiser Permanente Northern California
-
Stanford, California, Förenta staterna, 94305
- Stanford University
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
-
-
Tennessee
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University Medical Center
-
-
Texas
-
Dallas, Texas, Förenta staterna, 95226
- Baylor Scott & White
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
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:
- 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.
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Early Notification
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. |
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. |
|
Inget ingripande: Delayed Notification
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lipid-lowering therapy initiation or intensification (LLTI)
Tidsram: 6 months after participant randomization
|
|
6 months after participant randomization
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Aspirin prescription
Tidsram: 6 months after participant randomization
|
Number of new Aspirin or other antiplatelet prescription |
6 months after participant randomization
|
|
Lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides) ordering
Tidsram: 6 months after participant randomization
|
Number of Lipid panel ordering |
6 months after participant randomization
|
|
Lipoprotein(a) test ordering
Tidsram: 6 months after participant randomization
|
Number of Lipoprotein(a) test ordering |
6 months after participant randomization
|
|
Changes of total cholesterol, HDL-C, LDL-C, triglycerides, Lipoprotein(a) levels
Tidsram: 6 months after participant randomization
|
This outcome measure the changes of the test levels |
6 months after participant randomization
|
|
Healthcare resource use
Tidsram: Baseline through Month 6
|
|
Baseline through Month 6
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Fatima Rodriguez, MD, MPH, Stanford University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 84062
Plan för individuella deltagardata (IPD)
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