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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01227499
Other study ID # huashan001
Secondary ID
Status Completed
Phase N/A
First received October 22, 2010
Last updated May 2, 2014
Start date June 2010
Est. completion date November 2011

Study information

Verified date May 2014
Source Huashan Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 169
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 85 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- unwilling

- taking antithyroid drug or beta receptor blocker

- taking foods or medicine rich in iodine in 8 weeks

- women with pregnant or lactation

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Xiaolong Zhao Shanghai Shanghai

Sponsors (3)

Lead Sponsor Collaborator
xiaolong zhao Fudan University, Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other thyroid funciton December 1, 2013 No
Primary mean STA-PSV the mean STA-PSV 2014-04-07 No
Primary uptake of iodine December 1, 2013 Yes
Secondary PSV December 1, 2013 Yes
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