Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study
FATS
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
1 other identifier
observational
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 26, 2006
CompletedFirst Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2012
CompletedDecember 16, 2021
December 1, 2021
5.4 years
September 11, 2009
December 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Carotid Intima-media Thickness
Up to 3 years
Study Arms (2)
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 Criteria
Subjects known to have Atheroscloerosis.
You may qualify if:
- 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".
You may not qualify if:
- No past or present participation in the FATS OS Study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98105, United States
Related Publications (1)
Phan BA, Moore AB, Davis J, Pollan LJ, Neradilek B, Brown BG, Zhao XQ. Prolonged combination lipid therapy is associated with reduced carotid intima-media thickness: a case-control study of the 20-year Familial Atherosclerosis Treatment - Observational Study (FATS-OS). J Clin Lipidol. 2014 Sep-Oct;8(5):489-93. doi: 10.1016/j.jacl.2014.07.004. Epub 2014 Jul 12.
PMID: 25234561RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xue-Qiao Zhao, MD
University of Washington
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor of Medicine, Cardiology
Study Record Dates
First Submitted
September 11, 2009
First Posted
September 14, 2009
Study Start
December 26, 2006
Primary Completion
May 9, 2012
Study Completion
May 9, 2012
Last Updated
December 16, 2021
Record last verified: 2021-12