Atlantic Lipid Lowering Treatment Optimization Program

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorAtlantic Health System

About this trial

Hypercholesterolemia is recognized as the major driver for cardiovascular morbidity and mortality. To help address this in our community, Atlantic Medical Group (AMG) formed a lipid workgroup chaired by Robert D. Fishberg, MD, and Jeffrey N. Feldman, MD. The overarching goal of the lipid workgroup is to enhance the treatment of lipid disorders in those patients with abnormal lipid levels by improving access to resources at the primary care practice level and specialty level. We aim to develop a model for primary and secondary prevention that integrates guidelines for treatment at the practice level. Our primary objective is to identify high-risk patients by utilizing the electronic health record and partnering with patients' primary care providers to provide comprehensive medical management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Individuals who are pregnant

Individuals who are incarcerated

Individuals with a terminal illness

Individuals who do not consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Supportive care

    Other intervention

    The study model will utilize the accepted standard of care while implementing key enhancements to proactively reach high-risk patients as early as possible. Wrap around comprehensive care is defined as database screening, outreach, encouraging genetic testing for participants and their family members, and provide ongoing education, medical management (e.g., adherence to FDA-approved medications), routine laboratory testing, specialist referrals, Epic referrals to integrated care support such as pharmacy, nutrition, social work, and community health), and routine follow-up either in-person or using virtual visits. Consultations with pharmacists, nutritionists and genetic counselors or specialists to manage co-morbidities may be requested.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: LDL-COther 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with LDL-C maintenance<100

LDL-C \<100 mg/dL after at least six months of therapy

Time frame
6 months from enrollment in study

Secondary outcomes

1

Proportion of patients with LDL-C reaching <75

LDL-C \<75 mg/DL

Time frame
6 months from enrollment in study
2

Proportion of patients with LDL-C reaching <55

LDL-C \< 55mg/DL

Time frame
6 months from enrollment in study

Other outcomes

Sponsors and contacts

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Atlantic Health System

Lead sponsor

Regeneron Pharmaceuticals

Collaborator