NCT05786846

Brief Summary

This study investigated the changes in serum thyroid function and urinary iodine levels before and after the use of iodinated contrast to analyze the prevalence of thyroid dysfunction in the Chinese euthyroid adults after using iodinated contrast.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 30, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 16, 2023

Last Update Submit

May 26, 2023

Conditions

Thyroid Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of thyroid dysfunction after administration of iodine contrast agent.

    up to 32 weeks

Interventions

Iodinated contrast agentsDRUG

Patients who use iodinated contrast agents clinically

Also known as: Meglumine diatrizoate, Iopromide, Iohexol, Ioversol, Iopamidol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are identified of having undergone a radiological examination use of an iodinated contrast agent in Sun Yat-sen Memorial Hospital of Sun Yat-sen University

You may qualify if:

  • patients who use iodinated contrast agent

You may not qualify if:

  • patients with the following diseases: malignant tumor, critical illness (admitted to ICU), mental disease, hypothalamus-pituitary disease.
  • administration of anti-thyroid drugs (methimazole, propylthiouracil), levothyroxine, compound iodine solution, amiodarone, immunostaining point inhibitor, tyrosine kinase inhibitor, interferon, interleukin-6, lithium, glucocorticoids β Receptor blockers, dopamine, dobutamine, bromocriptine, octreotide, phenobarbital, phenytoin sodium, rifampicin, and carbamazepine within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital

Guangzhou, China

RECRUITING

MeSH Terms

Interventions

Diatrizoate MeglumineiopromideIohexolioversolIopamidol

Intervention Hierarchy (Ancestors)

MeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsDiatrizoateTriiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHexosaminesAmino SugarsCarbohydrates

Study Officials

  • Li Yan

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    STUDY DIRECTOR

Central Study Contacts

Li Yan

CONTACT

13719165213yanli@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

March 28, 2023

Study Start

February 15, 2023

Primary Completion

July 31, 2023

Study Completion

December 1, 2023

Last Updated

May 30, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)