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

NCT ID: NCT00976014

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-26

Study Completion Date

2012-05-09

Brief Summary

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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

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Conditions

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Carotid Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive Lipid-lowering therapy

Subjects on intensive long-term lipid lowering therapy (lowering LDL-C plus raising of HDL-C).

No interventions assigned to this group

Usual Care

Subjects with Atherosclerosis who have been on conventional "standard of care" treatment.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Xue-Qiao Zhao

Research Professor of Medicine, Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xue-Qiao Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25234561 (View on PubMed)

Other Identifiers

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30519

Identifier Type: -

Identifier Source: org_study_id