Atlantic Lipid Lowering Treatment Optimization Program

Not Applicable

Not yet recruiting

• Conditions: Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia; Familial Hypercholesterolemia; Apolipoprotein B 100, Familial Defective; High Density Lipoprotein Deficiency; Low-Density-Lipoid-Type Hyperlipoproteinemia
• Interventions: Other: Supportive care

• Registration Number: NCT06439654
• Lead Sponsor: Atlantic Health System

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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Study Start: 2024-06-01
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03
• Primary Completion: 2027-05-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LDL-C	Supportive care	Most recent LDL-C result

Primary Outcome Measures

Name	Time	Method
Proportion of patients with LDL-C maintenance<100	6 months from enrollment in study	LDL-C \<100 mg/dL after at least six months of therapy

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with LDL-C reaching <75	6 months from enrollment in study	LDL-C \<75 mg/DL
Proportion of patients with LDL-C reaching <55	6 months from enrollment in study	LDL-C \< 55mg/DL

Trial Locations

Locations (1)

Atlantic Medical Group; 🇺🇸 Springfield, New Jersey, United States