ThyrotoxicosisNCT01227499
Differential Diagnosis of STA-PSV in Thyrotoxicosis
An observational study of Thyrotoxicosis and Peak Systolic Velocity of Superior Thyroid Artery, run by xiaolong zhao at 1 site in China.
Trial summary
Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold standard to differential diagnosis the thyroiditis or Graves's disease. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Thyrotoxicosis, Peak Systolic Velocity of Superior Thyroid Artery, Thyroiditis
- How many people
- 169 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Nov 2011
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- newly diagnosed without taking any antithyroid drug or beta receptor blocker with TSH level below the lower limits of reference range
- is willing to be enrolled
Who cannot join
- unwilling
- taking antithyroid drug or beta receptor blocker
- taking foods or medicine rich in iodine in 8 weeks
- women with pregnant or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Diagnosis Value of Peak Systolic Velocity of Thyroid Superior Artery Using Color Flow Doppler Sonography in Transient Thyrotoxicosis Caused by Thyroiditis and Graves Disease
Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold standard to differential diagnosis the thyroiditis or Graves's disease. But the iodine uptake is limited for its availability in china and easily influenced by medicine or food contained iodine.The blood pattern of thyroid CFDS is useful for differentiate the cause of thyrotoxicosis.Most previous studies using the descriptive pattern of thyroid CFDS is easily varied by operator subjective judgement. This study is focus on the role of peak systolic velocity of thyroid superior artery in differential diagnosis of thyrotoxicosis. Methods: Patients with thyrotoxicosis symptoms without recent medicine history were enrolled in two clinical center. Its thyroid function, iodine uptake , CFDS of thyroid and peak systolic velocity of thyroid superior artery is detected. Thyrotoxicosis is defined as TSH level below the low value of normal range. Graves disease is defined as the typical symptoms of graves disease such as graves ophthalmopathy or increased iodine uptake. Thyroiditis is defined as lack of typical symptoms of graves disease or decreased iodine uptake.We use receiver operator curve(ROC) to evaluate its diagnosis value
- Conditions
- Thyrotoxicosis, Peak Systolic Velocity of Superior Thyroid Artery, Thyroiditis, Graves Disease
- Medical subject headings
- Thyrotoxicosis, Thyroiditis, Graves Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
mean STA-PSV
the mean STA-PSV
Measured: 2014-04-07
uptake of iodine
Measured: December 1, 2013
Secondary outcomes (1)
PSV
Measured: December 1, 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionNov 2011
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 ThyrotoxicosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- xiaolong zhao
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongda Hospital, Fudan University
- Responsible party
- Sponsor-investigator, xiaolong zhao, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227499
- Sponsor's protocol ID
- huashan001
- Status last verified
- May 2014
- First submitted
- 22 Oct 2010
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao X, Chen L, Li L, Wang Y, Wang Y, Zhou L, Zeng F, Li Y, Hu R, Liu H. Peak systolic velocity of superior thyroid artery for the differential diagnosis of thyrotoxicosis. PLoS One. 2012;7(11):e50051. doi: 10.1371/journal.pone.0050051. Epub 2012 Nov 16.
PubMed 23166817
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Diagnosis Value of Peak Systolic Velocity of Thyroid Superior Artery Using Color Flow Doppler Sonography in Transient Thyrotoxicosis Caused by Thyroiditis and Graves Disease
- ClinicalTrials.gov ID
- NCT01227499
- Acronym / sponsor ID
- huashan001
- Conditions
- Thyrotoxicosis, Peak Systolic Velocity of Superior Thyroid Artery, Thyroiditis, Graves Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- xiaolong zhaoUniversity, hospital or other
- Collaborators
- Zhongda Hospital, Fudan University
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 Oct 2010 (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.
Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold standard to differential diagnosis the thyroiditis or Graves's disease. But the iodine uptake is limited for its availability in china and easily influenced by medicine or food contained iodine.The blood pattern of thyroid CFDS is useful for differentiate the cause of thyrotoxicosis.Most previous studies using the descriptive pattern of thyroid CFDS is easily varied by operator subjective judgement. This study is focus on the role of peak systolic velocity of thyroid superior artery in differential diagnosis of thyrotoxicosis. Methods: Patients with thyrotoxicosis symptoms without recent medicine history were enrolled in two clinical center. Its thyroid function, iodine uptake , CFDS of thyroid and peak systolic velocity of thyroid superior artery is detected. Thyrotoxicosis is defined as TSH level below the low value of normal range. Graves disease is defined as the typical symptoms of graves disease such as graves ophthalmopathy or increased iodine uptake. Thyroiditis is defined as lack of typical symptoms of graves disease or decreased iodine uptake.We use receiver operator curve(ROC) to evaluate its diagnosis value
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- newly diagnosed without taking any antithyroid drug or beta receptor blocker with TSH level below the lower limits of reference range
- is willing to be enrolled
Key exclusion criteria (4 listed)
- unwilling
- taking antithyroid drug or beta receptor blocker
- taking foods or medicine rich in iodine in 8 weeks
- women with pregnant or lactation
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
mean STA-PSV
Time frame: 2014-04-07
the mean STA-PSV
uptake of iodine
Time frame: December 1, 2013
1 secondary outcome
PSV
Time frame: December 1, 2013
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 5 May 2014.
- Results publication: PubMed 23166817Zhao X, Chen L, Li L, Wang Y, Wang Y, Zhou L, Zeng F, Li Y, Hu R, Liu H. Peak systolic velocity of superior thyroid artery for the differential diagnosis of thyrotoxicosis. PLoS One. 2012;7(11):e50051. doi: 10.1371/journal.pone.0050051. Epub 2012 Nov 16.
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Thyrotoxicosis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thyrotoxicosis and Peak Systolic Velocity of Superior Thyroid Artery, run by xiaolong zhao at 1 site in China.
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 4 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 5 May 2014. 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 China. 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?
mean STA-PSV (time frame: 2014-04-07). The study lists 2 primary outcomes in all. 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 NCT01227499, 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 5 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.