<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04400409</url>
  </required_header>
  <id_info>
    <org_study_id>OPTIMIZE PAD-1</org_study_id>
    <nct_id>NCT04400409</nct_id>
  </id_info>
  <brief_title>Implementation of Vascular Care Team to Improve Medical Management of PAD Patients</brief_title>
  <official_title>Implementation of Vascular Care Team to Improve Medical Management of Peripheral Arterial Disease (PAD) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado Prevention Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Colorado Prevention Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study intends to evaluate the efficacy of a multidisciplinary vascular care team&#xD;
      utilizing an intensive guideline-based lipid reduction program in improving risk factor&#xD;
      modification as measured by LDL-C reduction at 12 months in patients with peripheral artery&#xD;
      disease (PAD). An additional objective is to understand the potential reach and impact if&#xD;
      this program were extended across the University of Colorado Healthcare (UC Health) System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and&#xD;
      who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach&#xD;
      including pharmacy and healthcare provider assistance with medication adherence, versus&#xD;
      Intervention B consisting of standard care augmented with a single consultation with a&#xD;
      Vascular Medicine physician who will provide the treating doctor with a personalized risk&#xD;
      assessment for the patient and a summary of the 2018 American College of Cardiology&#xD;
      (ACC)/American Heart Association (AHA) Guideline on Management of Blood. In order to&#xD;
      investigate the efficacy of the CPC Endpoint Quality Intervention Program (EQuIP), subjects&#xD;
      will additionally be randomized 1:1 to an investigative site conducted Six-Minute Walk Test&#xD;
      or an EQuIP team led Six-Minute Walk Test. Quality of Life data will be collected from all&#xD;
      subjects. There will also be an observational cohort (registry) to understand current&#xD;
      practice patterns and outcomes in a non-interventional PAD population within the UC Health&#xD;
      system in order to assess the potential impact of Intervention A after conclusion of the&#xD;
      randomized study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Month 12 LDL-C</measure>
    <time_frame>12 months</time_frame>
    <description>Percent change from baseline to month 12 in LDL-C</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Month 6 LDL-C</measure>
    <time_frame>6 months</time_frame>
    <description>Percent change from baseline at 6 months in LDL-C</description>
  </secondary_outcome>
  <other_outcome>
    <measure>EQ-5D-5L Quality of Life questionnaire</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Change from Baseline at months 6 and 12 in the EQ-5D-5L quality of life questionnaire.</description>
  </other_outcome>
  <other_outcome>
    <measure>Walking Impairment</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Change from Baseline at months 6 and 12 in the Walking Impairment Questionnaire (WIQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Distance Walked</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Change from Baseline at months 6 and 12 in the distance walked using the 6MWT.</description>
  </other_outcome>
  <other_outcome>
    <measure>Medication adherence</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Proportions of subjects at months 6 and 12 adherent to lipid-lowering therapy, determined by self-reporting</description>
  </other_outcome>
  <other_outcome>
    <measure>Biomarker levels</measure>
    <time_frame>12 months</time_frame>
    <description>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)])</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to endpoint events</measure>
    <time_frame>Time to event, up to 12 months</time_frame>
    <description>Time from Baseline to:&#xD;
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);&#xD;
MACE&#xD;
MALE&#xD;
Lower extremity revascularization;&#xD;
Coronary artery revascularization;&#xD;
Death;&#xD;
Any hospitalization</description>
  </other_outcome>
  <other_outcome>
    <measure>Impact of CPC EQuIP process</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Impact of CPC EQuIP process on variability in 6MWT at 6 and 12 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between venipuncture and dried dried blood spots</measure>
    <time_frame>12 months</time_frame>
    <description>Correlation between venipuncture and dried blood spot values of Baseline lipid and CRP levels</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>Intervention A + site 6MWT administration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention A subjects will receive a vascular care team approach to care including pharmacy and healthcare provider assistance with medication adherence.&#xD;
6-Minute Walk Test (6MWT) will be administered by site staff.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention B + site 6MWT administration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
6-Minute Walk Test (6MWT) will be administered by site staff.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention A + CPC EQuIP 6MWT administration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention A subjects will receive a vascular care team approach to care including pharmacy and healthcare provider assistance with medication adherence.&#xD;
6-Minute Walk Test (6MWT) will be administered by CPC EQuIP staff.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention B + CPC EQuIP 6MWT administration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
6-Minute Walk Test (6MWT) will be administered by CPC EQuIP staff.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention A - Vascular Care + site 6MWT administration</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention A + site 6MWT administration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention B - Standard Care + site 6MWT administration</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention B + site 6MWT administration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention A - Vascular Care + CPC EQuIP 6MWT administration</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention A + CPC EQuIP 6MWT administration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention B - Standard Care + CPC EQuIP 6MWT administration</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention B + CPC EQuIP 6MWT administration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Documented lower extremity atherosclerotic PAD with recommended goal LDL-C &lt;70 mg/dL&#xD;
             by the ACC/AHA Management of Blood Cholesterol Guidelines&#xD;
&#xD;
          2. Receiving care at CU Anschutz&#xD;
&#xD;
          3. Screening/baseline LDL-C ≥70 mg/dL without change in lipid lowering therapy within the&#xD;
             last 30 days prior to LDL-C draw.&#xD;
&#xD;
          4. Able to provide informed consent and willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling or unlikely to remain in the UC Health system through 1 year follow up (12&#xD;
             months after randomization)&#xD;
&#xD;
          2. Life expectancy &lt; 12 months&#xD;
&#xD;
          3. Fasting triglycerides &gt;400 mg/ml at screening&#xD;
&#xD;
          4. End-stage renal disease (eGRF&lt;15 mL/min/1.73m2 and/or renal replacement therapy)&#xD;
&#xD;
          5. History of nephrotic syndrome&#xD;
&#xD;
          6. Clinical evidence of severe liver disease or another medical condition for which lipid&#xD;
             lowering therapy may be contraindicated&#xD;
&#xD;
          7. Current enrollment in another investigational device or drug study with unapproved&#xD;
             devices or therapies or with therapies that would impact lipid levels or lipid therapy&#xD;
&#xD;
          8. Any other condition that in the opinion of the investigator would make the subject&#xD;
             unable to comply with the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Connie Hess, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CPC Clinical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>30423391</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29133605</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16171587</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16325694</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28304224</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26398078</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29330214</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16765240</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04400409
org study id: OPTIMIZE PAD-1
nct id: NCT04400409
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Month 12 LDL-C
time frame: 12 months
description: Percent change from baseline to month 12 in LDL-C
measure: Month 6 LDL-C
time frame: 6 months
description: Percent change from baseline at 6 months in LDL-C
measure: EQ-5D-5L Quality of Life questionnaire
time frame: 6 and 12 months
description: Change from Baseline at months 6 and 12 in the EQ-5D-5L quality of life questionnaire.
measure: Walking Impairment
time frame: 6 and 12 months
description: Change from Baseline at months 6 and 12 in the Walking Impairment Questionnaire (WIQ)
measure: Distance Walked
time frame: 6 and 12 months
description: Change from Baseline at months 6 and 12 in the distance walked using the 6MWT.
measure: Medication adherence
time frame: 6 and 12 months
description: Proportions of subjects at months 6 and 12 adherent to lipid-lowering therapy, determined by self-reporting
measure: Biomarker levels
time frame: 12 months
description: 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)])
measure: Time to endpoint events
time frame: Time to event, up to 12 months
description: Time from Baseline to:
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);
MACE
MALE
Lower extremity revascularization;
Coronary artery revascularization;
Death;
Any hospitalization
measure: Impact of CPC EQuIP process
time frame: 6 and 12 months
description: Impact of CPC EQuIP process on variability in 6MWT at 6 and 12 months
measure: Correlation between venipuncture and dried dried blood spots
time frame: 12 months
description: Correlation between venipuncture and dried blood spot values of Baseline lipid and CRP levels
arm group label: Intervention A + site 6MWT administration
arm group type: Active Comparator
description: 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.
arm group label: Intervention B + site 6MWT administration
arm group type: Active Comparator
description: 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.
arm group label: Intervention A + CPC EQuIP 6MWT administration
arm group type: Active Comparator
description: 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.
arm group label: Intervention B + CPC EQuIP 6MWT administration
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: Intervention A - Vascular Care + site 6MWT administration
description: 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.
arm group label: Intervention A + site 6MWT administration
intervention type: Other
intervention name: Intervention B - Standard Care + site 6MWT administration
description: 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.
arm group label: Intervention B + site 6MWT administration
intervention type: Other
intervention name: Intervention A - Vascular Care + CPC EQuIP 6MWT administration
description: 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.
arm group label: Intervention A + CPC EQuIP 6MWT administration
intervention type: Other
intervention name: Intervention B - Standard Care + CPC EQuIP 6MWT administration
description: 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.
arm group label: Intervention B + CPC EQuIP 6MWT administration
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Connie Hess, MD
role: Principal Investigator
affiliation: CPC Clinical Research
facility: 
country: United States
citation: 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.
PMID: 30423391
citation: 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: 29133605
citation: 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: 16171587
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PMID: 16765240
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
sharing ipd: No