Recruiting

Lipid Disorders

Sponsor:

Atlantic Health System

Code:

NCT06439654

Conditions

Familial Hypercholesterolemia

Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia

Apolipoprotein B 100, Familial Defective

High Density Lipoprotein Deficiency

Low-Density-Lipoid-Type Hyperlipoproteinemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Supportive care

Study Details

Brief summary:

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.

Conditions

Familial Hypercholesterolemia

Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia

Apolipoprotein B 100, Familial Defective

High Density Lipoprotein Deficiency

Low-Density-Lipoid-Type Hyperlipoproteinemia

Study ID

NCT06439654

Start date

Jul 1, 2024

Status verified date

Jul, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: LDL-C

Most recent LDL-C result

Interventions

Supportive care

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.

Primary outcome measure

  • Proportion of patients with LDL-C maintenance<100 [ Time Frame: 6 months from enrollment in study ]

Central Contacts and Locations

Central contacts

Robert D Fishberg, MD

973-467-0005robert.fishberg@atlantichealth.org

Jeffrey N Feldman, MD

908-686-9330jeffrey.feldman@atlantichealth.org

Locations

Atlantic Medical Group

Recruiting

Springfield, New Jersey, United States, 07081

Contacts

Robert D Fishberg, MD

973-467-0005robert.fishberg@atlantichealth.org

Jeffrey N Feldman, MD

908-686-9330jeffrey.feldman@atlantichealth.org

Principal Investigator:

Robert D Fishberg, MD

More Information

Sponsor

Atlantic Health System

Last update posted

Aug 3, 2025

Last verified

Jul, 2025

Keywords

  • LDL-C
  • FH
  • complex dyslipidemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2025-08-03.