Carotid StenosisFATSNCT00976014
Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study
An observational study of Carotid Stenosis, run by University of Washington at 1 site in United States.
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). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Carotid Stenosis
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2006to 9 May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects known to have Atheroscloerosis.
Who may be able to join
- 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".
Who cannot join
- No past or present participation in the FATS OS Study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Carotid Stenosis
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Intima-media Thickness
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study start26 Dec 2006
- Primary completion9 May 2012
- Study completion9 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue-Qiao Zhao, University of Washington
- Investigators
- Xue-Qiao Zhao, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976014
- Sponsor's protocol ID
- 30519
- Acronym
- FATS
- Status last verified
- Dec 2021
- First submitted
- 11 Sep 2009
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25234561
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00976014
- Acronym / sponsor ID
- FATS / 30519
- Conditions
- Carotid Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 26 Dec 2006 (actual)
- Primary completion
- 9 May 2012 (actual)
- Study completion
- 9 May 2012 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects known to have Atheroscloerosis.
Key inclusion criteria (2 listed)
- 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".
Key exclusion criteria (1 listed)
- No past or present participation in the FATS OS Study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Carotid Intima-media Thickness
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Results publication: PubMed 25234561Phan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xue-Qiao Zhao, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid Intima-media Thickness (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00976014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.