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FATS: Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT00976014
Collaborator
(none)
76
Enrollment
1
Location
64.4
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational study looks at Carotid Stenosis in two groups of subjects using a non-invasive procedure, B-mode ultrasound.

One group of subjects has had long-term intensive lipid altering therapy (lowering LDL-C plus raising HDL-C). The second group of patients has been on conventional "standard of care" treatment for carotid stenosis.

The study will look at the Carotid Intima-media Thickness (CMIT) in both groups.

Hypothesis: CIMT will differ between the two groups, such that the CIMT will be less in the subjects on intensive lipid altering therapy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    76 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Effects of Long-term Therapy With LDL-lowering Plus HDL Raising on Carotid Intima-media Thickness (CIMT) - Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study
    Actual Study Start Date :
    Dec 26, 2006
    Actual Primary Completion Date :
    May 9, 2012
    Actual Study Completion Date :
    May 9, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Intensive Lipid-lowering therapy

    Subjects on intensive long-term lipid lowering therapy (lowering LDL-C plus raising of HDL-C).
    Usual Care

    Subjects with Atherosclerosis who have been on conventional "standard of care" treatment.

    Outcome Measures

    Primary Outcome Measures

    1. Carotid Intima-media Thickness [Up to 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Intensive Lipid-lowering Therapy Group: Subjects currently enrolled in the Familial Atherosclerosis Treatment Observational Study.

    • Usual Care Group: Subjects who were in the FATS OS Study in the past, but have since quit the study and opted for conventional "standard of treatment".

    Exclusion Criteria:
    • No past or present participation in the FATS OS Study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Washington Seattle Washington United States 98105

    Sponsors and Collaborators

    • University of Washington

    Investigators

    • Principal Investigator: Xue-Qiao Zhao, MD, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xue-Qiao Zhao, Research Professor of Medicine, Cardiology, University of Washington
    ClinicalTrials.gov Identifier:
    NCT00976014
    Other Study ID Numbers:
    • 30519
    First Posted:
    Sep 14, 2009
    Last Update Posted:
    Dec 16, 2021
    Last Verified:
    Dec 1, 2021
    Additional relevant MeSH terms:
    Carotid Stenosis
    Atherosclerosis

    Study Results

    No Results Posted as of Dec 16, 2021