- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04400409
Implementation of Vascular Care Team to Improve Medical Management of PAD Patients
Implementation of Vascular Care Team to Improve Medical Management of Peripheral Arterial Disease (PAD) Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention A + site 6MWT administration
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. |
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.
|
Active Comparator: Intervention B + site 6MWT administration
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. |
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.
|
Active Comparator: Intervention A + CPC EQuIP 6MWT administration
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. |
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.
|
Active Comparator: Intervention B + CPC EQuIP 6MWT administration
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Month 12 LDL-C
Time Frame: 12 months
|
Percent change from baseline to month 12 in LDL-C
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Month 6 LDL-C
Time Frame: 6 months
|
Percent change from baseline at 6 months in LDL-C
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EQ-5D-5L Quality of Life questionnaire
Time Frame: 6 and 12 months
|
Change from Baseline at months 6 and 12 in the EQ-5D-5L quality of life questionnaire.
|
6 and 12 months
|
Walking Impairment
Time Frame: 6 and 12 months
|
Change from Baseline at months 6 and 12 in the Walking Impairment Questionnaire (WIQ)
|
6 and 12 months
|
Distance Walked
Time Frame: 6 and 12 months
|
Change from Baseline at months 6 and 12 in the distance walked using the 6MWT.
|
6 and 12 months
|
Medication adherence
Time Frame: 6 and 12 months
|
Proportions of subjects at months 6 and 12 adherent to lipid-lowering therapy, determined by self-reporting
|
6 and 12 months
|
Biomarker levels
Time Frame: 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)])
|
12 months
|
Time to endpoint events
Time Frame: Time to event, up to 12 months
|
Time from Baseline to:
|
Time to event, up to 12 months
|
Impact of CPC EQuIP process
Time Frame: 6 and 12 months
|
Impact of CPC EQuIP process on variability in 6MWT at 6 and 12 months
|
6 and 12 months
|
Correlation between venipuncture and dried dried blood spots
Time Frame: 12 months
|
Correlation between venipuncture and dried blood spot values of Baseline lipid and CRP levels
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Connie Hess, MD, CPC Clinical Research
Publications and helpful links
General Publications
- 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. Erratum In: J Am Coll Cardiol. 2019 Jun 25;73(24):3234-3237.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPTIMIZE PAD-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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