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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00976014
First received: September 11, 2009
Last updated: September 18, 2009
Last verified: September 2009
History of Changes
  Purpose

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
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:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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)
Groups/Cohorts
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects known to have Atheroscloerosis.

Criteria

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 ClinicalTrials.gov identifier: NCT00976014

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

No publications provided

Responsible Party: Xue-Qiao Zhao, University of Washington
ClinicalTrials.gov 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:
Atherosclerosis
Carotid Stenosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
 Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013