Atlantic program to optimize cholesterol-lowering care
Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP): A Comprehensive Approach to the Treatment of Familial Hypercholesterolemia and Complex Dyslipidemias
NA · Atlantic Health System · NCT06439654
This program will try coordinated outreach with primary care providers to lower LDL-C in people with familial hypercholesterolemia or LDL-C ≥160 mg/dL.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Atlantic Health System (other) |
| Locations | 2 sites (Clark, New Jersey and 1 other locations) |
| Trial ID | NCT06439654 on ClinicalTrials.gov |
What this trial studies
The program uses EHR screening to identify people with high LDL-C (≥160 mg/dL) or other markers of familial hypercholesterolemia and notifies their primary care providers. Study staff will send secure messages to the providers and, unless the provider opts out, reach out to patients to offer comprehensive lipid management services and education. Interventions are supportive care and coordination to optimize guideline-directed lipid-lowering therapy, follow-up testing, and referrals as needed. The primary goal is to see if this outreach and coordinated care can lower participants' LDL-C below baseline and ideally to ≤100 mg/dL.
Who should consider this trial
Good fit: Ideal candidates are adults with LDL-C ≥160 mg/dL, untreated LDL-C ≥190 with a family history of coronary artery disease, known familial hypercholesterolemia, or prior MI without optimized lipid therapy.
Not a fit: Patients who are pregnant, incarcerated, terminally ill, not willing to consent, or already at optimized lipid control are unlikely to benefit from this outreach.
Why it matters
Potential benefit: If successful, the program could help more people reach target LDL-C levels and lower their risk of heart attacks and other cardiovascular events.
How similar studies have performed: Other EHR-based outreach and care-coordination programs have produced modest but measurable improvements in statin use and LDL-C control, although FH-specific outreach models are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * LDL-C ≥160 mg/dL * Untreated LDL-C ≥190 with family history of CAD * Prior MI and currently without optimized lipid-lowering therapy * Family history of CAD in first degree relative * Personal history of CAD * Untreated triglycerides \>500 * Elevated Lp(a) and/or high calcium scores * Consenting individuals Exclusion Criteria: * Individuals who are pregnant * Individuals who are incarcerated * Individuals with a terminal illness * Individuals who do not consent
Where this trial is running
Clark, New Jersey and 1 other locations
- Atlantic Medical Group — Clark, New Jersey, United States (NOT_YET_RECRUITING)
- Atlantic Medical Group — Springfield, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Robert D Fishberg, MD — Atlantic Health System
- Study coordinator: Robert D Fishberg, MD
- Email: robert.fishberg@atlantichealth.org
- Phone: 973-467-0005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Familial Hypercholesterolemia, Lipoprotein Types--Lp System Lp Hyperlipoproteinemia, Apolipoprotein B 100, Familial Defective, High Density Lipoprotein Deficiency, Low-Density-Lipoid-Type Hyperlipoproteinemia, LDL-C, FH, complex dyslipidemia