NCT04400409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

May 19, 2020

Last Update Submit

February 6, 2024

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Month 12 LDL-C

    Percent change from baseline to month 12 in LDL-C

    12 months

Secondary Outcomes (1)

  • Month 6 LDL-C

    6 months

Other Outcomes (8)

  • EQ-5D-5L Quality of Life questionnaire

    6 and 12 months

  • Walking Impairment

    6 and 12 months

  • Distance Walked

    6 and 12 months

  • +5 more other outcomes

Study Arms (4)

Intervention A + site 6MWT administration

ACTIVE COMPARATOR

Intervention A subjects will receive a vascular care team approach to care including pharmacy and healthcare provider assistance with medication adherence. 6-Minute Walk Test (6MWT) will be administered by site staff.

Other: Intervention A - Vascular Care + site 6MWT administration

Intervention B + site 6MWT administration

ACTIVE COMPARATOR

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. 6-Minute Walk Test (6MWT) will be administered by site staff.

Other: Intervention B - Standard Care + site 6MWT administration

Intervention A + CPC EQuIP 6MWT administration

ACTIVE COMPARATOR

Intervention A subjects will receive a vascular care team approach to care including pharmacy and healthcare provider assistance with medication adherence. 6-Minute Walk Test (6MWT) will be administered by CPC EQuIP staff.

Other: Intervention A - Vascular Care + CPC EQuIP 6MWT administration

Intervention B + CPC EQuIP 6MWT administration

ACTIVE COMPARATOR

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. 6-Minute Walk Test (6MWT) will be administered by CPC EQuIP staff.

Other: Intervention B - Standard Care + CPC EQuIP 6MWT administration

Interventions

Intervention A - Vascular Care + site 6MWT administrationOTHER

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.

Intervention A + site 6MWT administration
Intervention B - Standard Care + site 6MWT administrationOTHER

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.

Intervention B + site 6MWT administration
Intervention A - Vascular Care + CPC EQuIP 6MWT administrationOTHER

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.

Intervention A + CPC EQuIP 6MWT administration
Intervention B - Standard Care + CPC EQuIP 6MWT administrationOTHER

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.

Intervention B + CPC EQuIP 6MWT administration

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (8)

  • Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):3168-3209. doi: 10.1016/j.jacc.2018.11.002. Epub 2018 Nov 10. No abstract available.

    PMID: 30423391BACKGROUND

  • Bonaca MP, Nault P, Giugliano RP, Keech AC, Pineda AL, Kanevsky E, Kuder J, Murphy SA, Jukema JW, Lewis BS, Tokgozoglu L, Somaratne R, Sever PS, Pedersen TR, Sabatine MS. Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease: Insights From the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk). Circulation. 2018 Jan 23;137(4):338-350. doi: 10.1161/CIRCULATIONAHA.117.032235. Epub 2017 Nov 13.

    PMID: 29133605BACKGROUND

  • Conte MS, Bandyk DF, Clowes AW, Moneta GL, Namini H, Seely L. Risk factors, medical therapies and perioperative events in limb salvage surgery: observations from the PREVENT III multicenter trial. J Vasc Surg. 2005 Sep;42(3):456-64; discussion 464-5. doi: 10.1016/j.jvs.2005.05.001.

    PMID: 16171587BACKGROUND

  • Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5.

    PMID: 16325694BACKGROUND

  • Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.

    PMID: 28304224BACKGROUND

  • Bonaca MP, Braunwald E, Sabatine MS. Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction. N Engl J Med. 2015 Sep 24;373(13):1274-5. doi: 10.1056/NEJMc1508692. No abstract available.

    PMID: 26398078BACKGROUND

  • Arya S, Khakharia A, Binney ZO, DeMartino RR, Brewster LP, Goodney PP, Wilson PWF. Association of Statin Dose With Amputation and Survival in Patients With Peripheral Artery Disease. Circulation. 2018 Apr 3;137(14):1435-1446. doi: 10.1161/CIRCULATIONAHA.117.032361. Epub 2018 Jan 12.

    PMID: 29330214BACKGROUND

  • Rehring TF, Stolcpart RS, Sandhoff BG, Merenich JA, Hollis HW Jr. Effect of a clinical pharmacy service on lipid control in patients with peripheral arterial disease. J Vasc Surg. 2006 Jun;43(6):1205-10. doi: 10.1016/j.jvs.2006.02.019.

    PMID: 16765240BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Connie Hess, MD

    CPC Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 22, 2020

Study Start

July 7, 2020

Primary Completion

May 11, 2023

Study Completion

May 11, 2023

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)