Salute Migliorata con Monitoraggio del Rischio Arterioso Attraverso Implementazione Diffusa e Sforzi di Screening nell'ASCVD (HEARTWISE-ASCVD) (HEARTWISE)
Studio sul Rischio Arterioso con Miglioramento della Salute tramite Implementazione Diffusa e Sforzi di Screening nella Malattia CardioVascolare AteroSclerotica (HEARTWISE-ASCVD)
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
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Los Angeles, California, Stati Uniti, 90095
- University of California, Los Angeles
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Pleasanton, California, Stati Uniti, 94588
- Kaiser Permanente Northern California
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Stanford, California, Stati Uniti, 94305
- Stanford University
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke University Medical Center
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Stati Uniti, 95226
- Baylor Scott & White
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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Non-gated chest CT performed within the prior 2 years within the health system
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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
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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
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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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Nessun intervento: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Lipid-lowering therapy initiation or intensification (LLTI)
Lasso di tempo: 6 months after participant randomization
|
|
6 months after participant randomization
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Aspirin prescription
Lasso di tempo: 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
Lasso di tempo: 6 months after participant randomization
|
Number of Lipid panel ordering |
6 months after participant randomization
|
|
Lipoprotein(a) test ordering
Lasso di tempo: 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
Lasso di tempo: 6 months after participant randomization
|
This outcome measure the changes of the test levels |
6 months after participant randomization
|
|
Healthcare resource use
Lasso di tempo: Baseline through Month 6
|
|
Baseline through Month 6
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Fatima Rodriguez, MD, MPH, Stanford University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 84062
Piano per i dati dei singoli partecipanti (IPD)
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