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

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ClinicalTrials.gov Identifier: NCT00976014
Recruitment Status : Unknown
Verified September 2009 by University of Washington.
Recruitment status was:  Enrolling by invitation
First Posted : September 14, 2009
Last Update Posted : September 22, 2009
Information provided by:
University of Washington

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
Carotid Stenosis

Study Type : Observational
Estimated Enrollment : 55 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
Study Start Date : September 2006
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Carotid Intima-media Thickness [ Time Frame: Up to 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects known to have Atheroscloerosis.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976014

United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Principal Investigator: Xue-Qiao Zhao University of Washington

Responsible Party: Xue-Qiao Zhao, University of Washington
ClinicalTrials.gov Identifier: NCT00976014     History of Changes
Other Study ID Numbers: 30519-E/A
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: September 22, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Carotid Stenosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases