Atlantic Lipid Lowering Treatment Optimization Program

NCT ID: NCT06439654

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-12-31

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.

Detailed Description

This study will screen patients with LDL-C >160 mg/dL and with evidence of familial hypertension, reach out (using secure chat) to the attending practitioner of such patients and inform the practitioner of our comprehensive services to address FH. A study team member will inform the practitioner that one of the study team plans to reach out to their patient to inform the patient of the study. Unless one of the study team receives notification by the practitioner that they want to opt out of this service for their patients, and do not want further interaction, the patient will be informed of the study and the consent process.

The research question is: Will an innovative comprehensive outreach approach, in conjunction with the primary care provider, reduce LDL-C levels in individuals with familial hypercholesteremia below individual baseline values, ideally at a level at or below 100 mg/dL.

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

LDL-C

Most recent LDL-C result

Group Type: OTHER

Supportive care

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Atlantic Health System

OTHER

Sponsor Role: lead

Responsible Party

Robert Fishberg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert D Fishberg, MD

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System

Locations

Atlantic Medical Group

Clark, New Jersey, United States

Site Status: NOT_YET_RECRUITING

Atlantic Medical Group

Springfield, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert D Fishberg, MD

Role: CONTACT

robert.fishberg@atlantichealth.org

973-467-0005

Jeffrey N Feldman, MD

Role: CONTACT

jeffrey.feldman@atlantichealth.org

908-686-9330

Facility Contacts

Robert D Fishberg, MD

Role: primary

robert.fishberg@atlantichealth.org

973-467-0005

Jeffrey N Feldman, MD

Role: backup

jeffrey.feldman@atlantichealth.org

908-686-9330

Robert D Fishberg, MD

Role: primary

robert.fishberg@atlantichealth.org

973-467-0005

Jeffrey N Feldman, MD

Role: backup

jeffrey.feldman@atlantichealth.org

908-686-9330

References

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Reference Type: BACKGROUND

PMID: 27050191 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 29080546 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26330422 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 36031461 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31331194 (View on PubMed)

Other Identifiers

2096455

Identifier Type: -

Identifier Source: org_study_id