Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP): A Comprehensive Approach to the Treatment of Familial Hypercholesterolemia and Complex Dyslipidemias
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Proportion of patients with LDL-C maintenance<100
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Individuals who are pregnant
- •Individuals who are incarcerated
- •Individuals with a terminal illness
- •Individuals who do not consent
结局指标
主要结局
Proportion of patients with LDL-C maintenance<100
时间窗: 6 months from enrollment in study
LDL-C \<100 mg/dL after at least six months of therapy
次要结局
- 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)
研究者
Robert Fishberg
Principal Investigator
Atlantic Health System