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Helseforbedret arterierisikosporing med utbredt implementering og screeninginnsats i ASCVD (HEARTWISE-ASCVD) (HEARTWISE)

11. november 2026 oppdatert av: Fatima Rodriguez, Stanford University

Helseforbedret Arterie Risiko Sporing med Utbredt Implementering og Screening InnSats i Atherosklerotisk Kardiovaskulær Sykdom (HEARTWISE-ASCVD) Studie

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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

12000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90095
        • University of California, Los Angeles
      • Pleasanton, California, Forente stater, 94588
        • Kaiser Permanente Northern California
      • Stanford, California, Forente stater, 94305
        • Stanford University
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, Forente stater, 95226
        • Baylor Scott & White

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 74 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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:

    1. Active enrollment in the site's integrated healthcare plan (e.g., Kaiser Permanente Northern California), OR
    2. LDL-C measured within the health system within the prior 2 years, OR
    3. Outpatient cardiovascular medication prescription within the prior year

  • Meets one of the following clinical criteria:

    1. Clinical ASCVD diagnosis (coronary artery disease, peripheral arterial disease, or ischemic cerebrovascular disease) AND AI-detected CAC >0 on non-gated chest CT, OR
    2. 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: AI-Detected CAC Notification and Care Facilitation

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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lipid-lowering therapy initiation or intensification (LLTI)
Tidsramme: 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
6 months after participant randomization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Aspirin prescription
Tidsramme: 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
Tidsramme: 6 months after participant randomization

Number of Lipid panel ordering
6 months after participant randomization
Lipoprotein(a) test ordering
Tidsramme: 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
Tidsramme: 6 months after participant randomization

This outcome measure the changes of the test levels
6 months after participant randomization
Healthcare resource use
Tidsramme: Baseline through Month 6
  • 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)
Baseline through Month 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Stanford University

Samarbeidspartnere

University of California, Los Angeles
Duke University
Vanderbilt University Medical Center
Kaiser Permanente
Amgen
Baylor Scott and White Health

Etterforskere

  • Hovedetterforsker: Fatima Rodriguez, MD, MPH, Stanford University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. august 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

12. januar 2026

Først innsendt som oppfylte QC-kriteriene

12. januar 2026

Først lagt ut (Faktiske)

21. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 84062

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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