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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Supportive care
Other interventionThe 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
Trial outcomes
Primary outcomes
Proportion of patients with LDL-C maintenance<100
LDL-C \<100 mg/dL after at least six months of therapy
Secondary outcomes
Proportion of patients with LDL-C reaching <75
LDL-C \<75 mg/DL
Proportion of patients with LDL-C reaching <55
LDL-C \< 55mg/DL
Sponsors and contacts
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Atlantic Health System
Lead sponsor
Regeneron Pharmaceuticals
Collaborator