NCT01227499

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

1.4 years

First QC Date

October 22, 2010

Last Update Submit

May 2, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • mean STA-PSV

    the mean STA-PSV

    2014-04-07

  • uptake of iodine

    December 1, 2013

Secondary Outcomes (1)

  • PSV

    December 1, 2013

Other Outcomes (1)

  • thyroid funciton

    December 1, 2013

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care clinic

You may qualify if:

  • 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

You may not qualify if:

  • unwilling
  • taking antithyroid drug or beta receptor blocker
  • taking foods or medicine rich in iodine in 8 weeks
  • women with pregnant or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaolong Zhao

Shanghai, Shanghai Municipality, 200040, China

Location

Related 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.

MeSH Terms

Conditions

ThyrotoxicosisThyroiditisGraves Disease

Condition Hierarchy (Ancestors)

HyperthyroidismThyroid DiseasesEndocrine System DiseasesExophthalmosOrbital DiseasesEye DiseasesGoiterAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
endocrinology department

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 25, 2010

Study Start

June 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations