Thyroid DysfunctionNCT05786846
Serum Thyroid Function After Iodinated Contrast Administration
An observational study of Thyroid Dysfunction, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Dysfunction
- What is being tested?
- Iodinated contrast agents
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 1 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- patients who use iodinated contrast agent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital
Guangzhou
Li Yan, 13719165213, yanli@mail.sysu.edu.cn
About this study
Official title: Serum Thyroid Function After Iodinated Contrast Administration in Chinese Euthyroid Adults: a Prospective Observational Study.
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.
Read the detailed description
This study aims to monitor the thyroid function, urinary iodine level, and other indicators of patients after using iodine contrast agents, in order to analyze the prevalence of thyroid dysfunction after using iodine containing contrast agents, and investigate the impact of different iodine contrast agents on thyroid function, in order to provide evidence for the use of iodine contrast agents in clinical practice and the risk prevention of subsequent thyroid diseases.
- Conditions
- Thyroid Dysfunction
- Being tested
- Iodinated contrast agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodinated contrast agentsDrug
Also called Meglumine diatrizoate, Iopromide, Iohexol, Ioversol
Patients who use iodinated contrast agents clinically
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of thyroid dysfunction after administration of iodine contrast agent.
Measured: up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start15 Feb 2023
- Primary completion31 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DysfunctionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Yan, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786846
- Sponsor's protocol ID
- SYSEC-KY-KS-2022-002
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Thyroid Function After Iodinated Contrast Administration in Chinese Euthyroid Adults: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05786846
- Acronym / sponsor ID
- SYSEC-KY-KS-2022-002
- Conditions
- Thyroid Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Mar 2023 (actual)
- 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 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.
Detailed description
This study aims to monitor the thyroid function, urinary iodine level, and other indicators of patients after using iodine contrast agents, in order to analyze the prevalence of thyroid dysfunction after using iodine containing contrast agents, and investigate the impact of different iodine contrast agents on thyroid function, in order to provide evidence for the use of iodine contrast agents in clinical practice and the risk prevention of subsequent thyroid diseases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients who use iodinated contrast agent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodinated contrast agentsAlso: Meglumine diatrizoate, Iopromide, Iohexol, IoversolPatients who use iodinated contrast agents clinically | Drug | – |
Primary outcome
Incidence rate of thyroid dysfunction after administration of iodine contrast agent.
Time frame: up to 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: No
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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.
Li Yan study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Thyroid Dysfunction, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yan (13719165213, yanli@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of thyroid dysfunction after administration of iodine contrast agent. (time frame: up to 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2023.