Atlantic Lipid Lowering Treatment Optimization Program

NCT06439654 | Recruiting

• 1 other identifier: 2096455
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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

Keywords

LDL-C; FH; complex dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with LDL-C maintenance<100

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

  6 months from enrollment in study

Secondary Outcomes (2)

• Proportion of patients with LDL-C reaching <75

  6 months from enrollment in study

• Proportion of patients with LDL-C reaching <55

  6 months from enrollment in study

Study Arms (1)

LDL-C

OTHER

Most recent LDL-C result

Other: Supportive care

Interventions

Supportive care OTHER

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.

LDL-C

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals who are pregnant
• Individuals who are incarcerated
• Individuals with a terminal illness
• Individuals who do not consent

Sponsors & Collaborators

• Atlantic Health System: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (2)

Atlantic Medical Group

Clark, New Jersey, 07066, United States

NOT YET RECRUITING

Atlantic Medical Group

Springfield, New Jersey, 07081, United States

RECRUITING

Related Publications (6)

• Khera AV, Won HH, Peloso GM, Lawson KS, Bartz TM, Deng X, van Leeuwen EM, Natarajan P, Emdin CA, Bick AG, Morrison AC, Brody JA, Gupta N, Nomura A, Kessler T, Duga S, Bis JC, van Duijn CM, Cupples LA, Psaty B, Rader DJ, Danesh J, Schunkert H, McPherson R, Farrall M, Watkins H, Lander E, Wilson JG, Correa A, Boerwinkle E, Merlini PA, Ardissino D, Saleheen D, Gabriel S, Kathiresan S. Diagnostic Yield and Clinical Utility of Sequencing Familial Hypercholesterolemia Genes in Patients With Severe Hypercholesterolemia. J Am Coll Cardiol. 2016 Jun 7;67(22):2578-89. doi: 10.1016/j.jacc.2016.03.520. Epub 2016 Apr 3.

  PMID: 27050191 BACKGROUND

• Amrock SM, Duell PB, Knickelbine T, Martin SS, O'Brien EC, Watson KE, Mitri J, Kindt I, Shrader P, Baum SJ, Hemphill LC, Ahmed CD, Andersen RL, Kullo IJ, McCann D, Larry JA, Murray MF, Fishberg R, Guyton JR, Wilemon K, Roe MT, Rader DJ, Ballantyne CM, Underberg JA, Thompson P, Duffy D, Linton MF, Shapiro MD, Moriarty PM, Knowles JW, Ahmad ZS. Health disparities among adult patients with a phenotypic diagnosis of familial hypercholesterolemia in the CASCADE-FH patient registry. Atherosclerosis. 2017 Dec;267:19-26. doi: 10.1016/j.atherosclerosis.2017.10.006. Epub 2017 Oct 6.

  PMID: 29080546 BACKGROUND

• Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015 Nov 14;36(43):2996-3003. doi: 10.1093/eurheartj/ehv370. Epub 2015 Sep 1.

  PMID: 26330422 BACKGROUND

• Alam L, Fishberg R, Echeverry T, Feldman J. Screening for familial hypercholesterolemia using Epic Secure Chat in comparison to Epic Letter as educational outreach. Journal of Clinical Lipidology. 2022;16(1):e20-e21. doi.org/10.1016/j.jacl.2021.09.029

  BACKGROUND

• Writing Committee; Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Covington AM, DePalma SM, Minissian MB, Orringer CE, Smith SC Jr, Waring AA, Wilkins JT. 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022 Oct 4;80(14):1366-1418. doi: 10.1016/j.jacc.2022.07.006. Epub 2022 Aug 25. No abstract available.

  PMID: 36031461 BACKGROUND

• Myers KD, Farboodi N, Mwamburi M, Howard W, Staszak D, Gidding S, Baum SJ, Wilemon K, Rader DJ. Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes. Circ Cardiovasc Qual Outcomes. 2019 Aug;12(8):e005404. doi: 10.1161/CIRCOUTCOMES.118.005404. Epub 2019 Jul 23.

  PMID: 31331194 BACKGROUND

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia; Hypoalphalipoproteinemias

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypolipoproteinemias

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Robert D Fishberg, MD

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert D Fishberg, MD

CONTACT

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

Jeffrey N Feldman, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective quantitative study of individuals with FH to examine the benefit of comprehensive supportive care to lower elevated LDL-C and sustain healthy levels through 36 months from baseline enrollment. We propose to demonstrate improvement in lipid parameters and outcomes in patients referred to the study. Specifically, we will target patients with documented hypercholesterolemia, hypertriglyceridemia, prior myocardial infarction, and personal or family history of coronary artery disease, who may be living with undiagnosed/untreated familial hypercholesterolemia FH.

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)