Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study

Completed

• Conditions: Carotid Stenosis

• Registration Number: NCT00976014
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-26
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2012-05-09
• Study Completion: 2012-05-09
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

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".

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Exclusion Criteria

• No past or present participation in the FATS OS Study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Carotid Intima-media Thickness	Up to 3 years

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States