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

Carotid Stenosis Clinical Trial

— FATS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976014
• Other study ID #: 30519
• Status: Completed
• Start date: December 26, 2006
• Est. completion date: May 9, 2012

Study information

• Verified date: December 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 9, 2012
• Est. primary completion date: May 9, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Stenosis

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & 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 St — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid Intima-media Thickness		Up to 3 years