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Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT01776151
Collaborator
(none)
337
Enrollment
1
Location
70
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    337 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
    Study Start Date :
    Nov 1, 2009
    Actual Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Sep 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in large artery elasticity (LAE [baseline, Months 1, 4, 8, 12, annually thereafter]

      Large artery elasticity is measured using a tonometer placed on the forearm.

    2. Change from baseline in small artery elasticity (SAE) [baseline, Months 1, 4, 8, 12, annually thereafter]

      Small artery elasticity is measured using a tonometer placed on the forearm.

    Secondary Outcome Measures

    1. Changes in plasma markers of thrombosis and fibrinolysis [baseline, months 4, 8, 12, annually thereafter]

      Citrated plasma will be collected and stored for central measurement of plasma markers of thrombosis and fibrinolysis in the future.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Simultaneous co-enrollment in the START study

    • Signed informed consent

    Exclusion Criteria:
    • Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henry Ford Health System Detroit Michigan United States 48202

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    • Study Chair: Jason V Baker, MD, University of Minnesota
    • Study Chair: Daniel Duprez, MD, PhD, University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT01776151
    Other Study ID Numbers:
    • 0603M83587-3
    First Posted:
    Jan 25, 2013
    Last Update Posted:
    Nov 1, 2019
    Last Verified:
    Oct 1, 2019
    Keywords provided by University of Minnesota
    HIV
    cardiovascular diseases
    vascular stiffness
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Nov 1, 2019