Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study (FATS)

December 1, 2021 updated by: Xue-Qiao Zhao, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Subjects known to have Atheroscloerosis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Carotid Intima-media Thickness
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2006

Primary Completion (Actual)

May 9, 2012

Study Completion (Actual)

May 9, 2012

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30519

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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