Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07355894
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT07355894
Study Brief:
Protocol Section:
NCT07355894