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

This study is enrolling participants by invitation only.
Information provided by:
University of Washington Identifier:
First received: September 11, 2009
Last updated: September 18, 2009
Last verified: September 2009

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.

Carotid Stenosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Carotid Intima-media Thickness [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: September 2006
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.


Genders 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.
  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Xue-Qiao Zhao, University of Washington Identifier: NCT00976014     History of Changes
Other Study ID Numbers: 30519-E/A
Study First Received: September 11, 2009
Last Updated: September 18, 2009
Health Authority: United States: Institutional Review Board

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 processed this record on April 17, 2014