Status:
COMPLETED
Implementation of Vascular Care Team to Improve Medical Management of PAD Patients
Lead Sponsor:
Colorado Prevention Center
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study intends 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 b...
Detailed Description
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 phar...
Eligibility Criteria
Inclusion
- Documented lower extremity atherosclerotic PAD with recommended goal LDL-C \<70 mg/dL by the ACC/AHA Management of Blood Cholesterol Guidelines
- Receiving care at CU Anschutz
- Screening/baseline LDL-C ≥70 mg/dL without change in lipid lowering therapy within the last 30 days prior to LDL-C draw.
- Able to provide informed consent and willing to participate
Exclusion
- Unwilling or unlikely to remain in the UC Health system through 1 year follow up (12 months after randomization)
- Life expectancy \< 12 months
- Fasting triglycerides \>400 mg/ml at screening
- End-stage renal disease (eGRF\<15 mL/min/1.73m2 and/or renal replacement therapy)
- History of nephrotic syndrome
- Clinical evidence of severe liver disease or another medical condition for which lipid lowering therapy may be contraindicated
- 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
- Any other condition that in the opinion of the investigator would make the subject unable to comply with the protocol
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04400409
Start Date
July 7 2020
End Date
May 11 2023
Last Update
February 8 2024
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045