The primary objective of the study is to evaluate the efficacy of a multidisciplinary vascular care team utilizing an intensive guideline-based lipid reduction program in improving risk factor modification as measured by LDL-C reduction at 12 months in patients with peripheral artery disease (PAD). An additional objective is to understand the potential reach and impact if this program were extended across the University of Colorado Healthcare (UC Health) System.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: November 2021
Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood.1 There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study.
- Other: Intervention A – Vascular Care Team Approach
- consists of multiple strategies related to improving lipid management, starting with a referral to the vascular care team. The subject will undergo a visit with a vascular care team, including a Vascular Medicine specialist who will obtain a patient history and prescribe a lipid lowering therapy regimen. The subject will also meet with a pharmacist to answer questions related to access to medications, drug side effects, and potential interactions with the subject’s other medications.
- Other: Intervention B – Standard Care
- Consists of provision of the treating provider with a copy of the 2018 ACC/AHA Guidelines on the Management of Blood Cholesterol. Subjects will return at 6 and 12 months for lab draws and endpoint event assessments but will not meet with vascular care team.
Arms, Groups and Cohorts
- Experimental: Intervention A – Vascular Care Team Approach
- Intervention A subjects will receive a vascular care team approach to care including pharmacy and healthcare provider assistance with medication adherence.
- Active Comparator: Intervention B – Standard Care
- Intervention B will receive standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood.
Clinical Trial Outcome Measures
- Month 12 LDL-C
- Time Frame: 12 months
- Percent change from baseline to month 12 in LDL-C
- Month 6 LDL-C
- Time Frame: 6 months
- Percent change from baseline at 6 months in LDL-C
Participating in This Clinical Trial
1. Documented lower extremity atherosclerotic PAD with recommended goal LDL-C <70 mg/dL by the ACC/AHA Management of Blood Cholesterol Guidelines
2. Receiving care at CU Anschutz
3. Screening/baseline LDL-C ≥70 mg/dL without change in lipid lowering therapy within the last 30 days prior to LDL-C draw.
4. Able to provide informed consent and willing to participate
1. Unwilling or unlikely to remain in the UC Health system through 1 year follow up (12 months after randomization)
2. Life expectancy < 12 months
3. Fasting triglycerides >400 mg/ml at screening
4. End-stage renal disease (eGRF<15 mL/min/1.73m2 and/or renal replacement therapy)
5. History of nephrotic syndrome
6. Clinical evidence of severe liver disease or another medical condition for which lipid lowering therapy may be contraindicated
7. Current enrollment in another investigational device or drug study with unapproved devices or therapies or with therapies that would impact lipid levels or lipid therapy
8. Any other condition that in the opinion of the investigator would make the subject unable to comply with the protocol
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Colorado Prevention Center
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Connie Hess, MD, 303-860-9900, email@example.com
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