Peripheral Artery Disease
Conditions
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 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.
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 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. In order to investigate the efficacy of the CPC Endpoint Quality Intervention Program (EQuIP), subjects will additionally be randomized 1:1 to an investigative site conducted Six-Minute Walk Test or an EQuIP team led Six-Minute Walk Test. Quality of Life data will be collected from all subjects. 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.
Interventions
OTHERIntervention A - Vascular Care + site 6MWT administration
Implementation 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. Additionally, the site staff will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
OTHERIntervention B - Standard Care + site 6MWT administration
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. Additionally, the site staff will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
OTHERIntervention A - Vascular Care + CPC EQuIP 6MWT administration
Implementation 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. Additionally, the CPC EQuIP team will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
OTHERIntervention B - Standard Care + CPC EQuIP 6MWT administration
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. Additionally, the CPC EQuIP team will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
Sponsors
Colorado Prevention Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Month 12 LDL-C | 12 months | Percent change from baseline to month 12 in LDL-C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Month 6 LDL-C | 6 months | Percent change from baseline at 6 months in LDL-C |
Other
| Measure | Time frame | Description |
|---|---|---|
| Distance Walked | 6 and 12 months | Change from Baseline at months 6 and 12 in the distance walked using the 6MWT. |
| Medication adherence | 6 and 12 months | Proportions of subjects at months 6 and 12 adherent to lipid-lowering therapy, determined by self-reporting |
| Biomarker levels | 12 months | Change from Baseline at 12 months in the levels of biomarkers (e.g. C-reactive protein \[CRP\], troponin, brain natriuretic peptide \[BNP\], lipoprotein(a) \[Lp(a)\]) |
| EQ-5D-5L Quality of Life questionnaire | 6 and 12 months | Change from Baseline at months 6 and 12 in the EQ-5D-5L quality of life questionnaire. |
| Impact of CPC EQuIP process | 6 and 12 months | Impact of CPC EQuIP process on variability in 6MWT at 6 and 12 months |
| Correlation between venipuncture and dried dried blood spots | 12 months | Correlation between venipuncture and dried blood spot values of Baseline lipid and CRP levels |
| Time to endpoint events | Time to event, up to 12 months | Time from Baseline to: 1. Major adverse cardiovascular events (MACE) (myocardial infarction \[MI\], ischemic stroke, or cardiovascular death) or major adverse limb event (MALE) (major amputation or acute limb ischemia); 2. MACE 3. MALE 4. Lower extremity revascularization; 5. Coronary artery revascularization; 6. Death; 7. Any hospitalization |
| Walking Impairment | 6 and 12 months | Change from Baseline at months 6 and 12 in the Walking Impairment Questionnaire (WIQ) |
Countries
United States
Outcome results
None listed