Hyperthyroidism/ThyrotoxicosisNCT04304794
Iodinated Contrast Media Induced Hyperthyroidism
An observational study of Hyperthyroidism/Thyrotoxicosis and Hyperthyroidism; Goiter, run by Medical University of Warsaw.
Trial summary
The proper synthesis of thyroid hormones is dependent on adequate iodine supply. The mean daily iodine intake recommended by World Health Organization is 150 mg. Iodinated contrast medium (ICM) typically contains 13 500 mg of free iodine and 15-60 g of bound iodine, an amount well above acceptable upper level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperthyroidism/Thyrotoxicosis, Hyperthyroidism; Goiter, Iodine Induced Thyrotoxicosis
- What is being tested?
- Administration of iodinated contrast media and Prophylactic administration of antithyroid drugs before iodinated contrast media exposure
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2015to 20 Feb 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 36 patients (15 males) with euthyroid goiter and cardiovascular comorbidities admitted to the Institute of Cardiology between January 2015 and November 2019. The median age of treated patients was 68 years old.
Who may be able to join
- euthyroidism at baseline (defined as TSH level within the reference range)
- diffuse or multinodular goiter
- iodinated contrast media (ICM) exposure
- time of observation after ICM exposure longer than 4 weeks
Who cannot join
- Graves' disease
- administration of thyroid hormones, glucocorticoids, iodine-containing medications or iodine contrast agent within the past 6 months
About this study
Official title: Prevention of Iodinated Contrast Media Induced Hyperthyroidism in Patients With Euthyroid Goiter
The proper synthesis of thyroid hormones is dependent on adequate iodine supply. The mean daily iodine intake recommended by World Health Organization is 150 mg. Iodinated contrast medium (ICM) typically contains 13 500 mg of free iodine and 15-60 g of bound iodine, an amount well above acceptable upper level. In a situation of excess iodine, thyroid discontinues the release of hormones (Wolff-Chaikoff effect), which is usually transient, although can persist causing hypothyroidism. Iodine-induced hyperthyroidism (IIH), known as the Jod-Basedow phenomenon is infrequent, but elderly patients and individuals with autonomously functioning nodular goiters are at higher risk of developing this dysfunction. According to recent studies the risk of ICM-induced hyperthyroidism appears to be low. The prevalence has not been well assessed and varies from 1 % to 10 %. Currently, there are no specific guidelines concerning the prophylactic therapy of IIH. American Thyroid Association (ATA) does not recommend routine administration of antithyroid drugs before iodinated contrast medium for all patients, however, advises to consider prophylaxis in patients at high risk of developing IIH or with cardiovascular comorbidities. ATA recommends avoidance of additional iodine and administration of b-blockers alone or with antithyroid drugs as a treatment of IIH, depending on the severity of hyperthyroidism.
This study was performed to evaluate the influence of ICM on thyroid status and advantages of prophylactic therapy during ICM exposure in patients with euthyroid goiter and cardiovascular comorbidities. The association between the incidence of IIH and thyroid volume was also assessed.
Read the detailed description
Patients were divided into two subsets on the basis of received prophylactic therapy. Group with prophylaxis (13 patients) received thiamazole alone (7 patients) or with sodium perchlorate (6 patients). The prophylaxis was administered one day prior to iodinated contrast medium (ICM) and for at least 14 days after ICM for thiamazole (20-40 mg/daily) and 10 days after ICM for sodium perchlorate (900 mg/daily). Group without prophylaxis (23 patients) received no prophylactic treatment. Laboratory tests were performed before and after ICM injection in all patients from both evaluated groups. Each individual had TSH and creatinine level measured at baseline. The investigators analyzed clinical data such as age, sex, mean volume of contrast media, goiter size and patients' comorbidities. Levels of TSH, FT3 and FT4 were evaluated retrospectively at different points in time after ICM. Ultrasonography was performed in each patient to assess thyroid morphology. The investigators performed a comparison between both groups in regard to duration of overt hyperthyroidism and thiamazole treatment. Thyroid volume was compared between patients who developed hyperthyroidism after ICM injection and remained euthyroid after ICM injection. Patients diagnosed with overt hyperthyroidism were treated with thiamazole.
- Conditions
- Hyperthyroidism/Thyrotoxicosis, Hyperthyroidism; Goiter, Iodine Induced Thyrotoxicosis, Contrast Media Adverse Reaction, Thyrotoxicosis of Other Specified Origin
- Being tested
- Administration of iodinated contrast media, Prophylactic administration of antithyroid drugs before iodinated contrast media exposure
- Keywords
- Hyperthyroidism, Iodinated contrast media, Euthyroid goiter, Thyroid nodules, Thyroid volume, Thiamazole, Sodium perchlorate
- Medical subject headings
- Hyperthyroidism, Thyrotoxicosis, Goiter, Euthyroid Goiter, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of iodinated contrast mediaProcedure or surgery
Each patient was exposed on iodinated contrast medium administered during computed tomography, coronary angiography or transcatheter aortic valve implantation.
Prophylactic administration of antithyroid drugs before iodinated contrast media exposureDrug
13 patients received thiamazole with (6 patients) or without (7 patients) sodium perchlorate, one day prior to iodinated contrast medium (ICM) and for at least 14 days after for thiamazole (20-40 mg/daily) and 10 days after for sodium perchlorate (900 mg/daily).
| Study group | Role | What they receive |
|---|---|---|
| Group with prophylaxis | Group of 13 patients with euthyroid goiter who received prophylactic treatment before and after iodinated contrast medium (ICM) injection. 6 patients received thiamazole with sodium perchlorate, one day prior to ICM and for at least 14 days after for thiamazole (20-40 mg/daily) and 10 days after for sodium perchlorate (900 mg/daily). 7 patients received only thiamazole as prophylactic treatment due to lack of sodium perchlorate at the time. Receives: Procedure: Administration of iodinated contrast media; Drug: Prophylactic administration of antithyroid drugs before iodinated contrast media exposure | |
| Group without prophylaxis | Group of 23 patients with euthyroid goiter who received no prophylactic treatment before iodinated contrast medium injection. Receives: Procedure: Administration of iodinated contrast media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of iodinated contrast medium administration on thyroid function.
Evaluation of TSH, FT3 and FT4 levels at different points in time after iodinated contrast medium injection. Normal thyroid function was defined as TSH levels between 0.27 and 4.20 mIU/L. The reference range for fT4 and fT3 was 0.93-1.7 ng/dl and 2.0-4.4 pg/ml, respectively.
Measured: up to 72 weeks
Evaluation of the association between the incidence of iodine-induced hyperthyroidism and thyroid volume.
Analysis of association between thyroid volume and changes in thyroid status after iodinated contrast medium injection. Normal thyroid function was defined as TSH levels between 0.27 and 4.20 mIU/L. The reference range for fT4 and fT3 was 0.93-1.7 ng/dl and 2.0-4.4 pg/ml, respectively. Subclinical hyperthyroidism was diagnosed on the basis of suppressed TSH and normal fT4 and fT3 values. Overt hyperthyroidism was defined as TSH level below lower limit and elevated fT4 and/or fT3 concentrations. Ultrasonography was performed in each patient to assess thyroid volume [ml]. Enlargement of the gland was defined as a volume exceeding 18 ml in females and 25 ml in males.
Measured: up to 72 weeks
Evaluation of the association between the incidence of iodine-induced hyperthyroidism and the use of prophylactic treatment with antithyroid drugs before and after iodinated-contrast medium injection.
Evaluation of TSH, FT3 and FT4 levels at different points in time after iodinated contrast medium injection and comparison between groups. Normal thyroid function was defined as TSH levels between 0.27 and 4.20 mIU/L. The reference range for fT4 and fT3 was 0.93-1.7 ng/dl and 2.0-4.4 pg/ml, respectively. Subclinical hyperthyroidism was diagnosed on the basis of suppressed TSH and normal fT4 and fT3 values. Overt hyperthyroidism was defined as TSH level below lower limit and elevated fT4 and/or fT3 concentrations.
Measured: up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start2 Jan 2015
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperthyroidism/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
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Cardiology, Warsaw, Poland
- Responsible party
- Principal investigator, Piotr Miskiewicz, Medical University of Warsaw
- Investigators
- Piotr Miśkiewicz, MD, PhD, Principal investigator, Department of Endocrinology Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304794
- Sponsor's protocol ID
- ICMThyro
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The collected data will be shared in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Iodinated Contrast Media Induced Hyperthyroidism in Patients With Euthyroid Goiter
- ClinicalTrials.gov ID
- NCT04304794
- Acronym / sponsor ID
- ICMThyro
- Conditions
- Hyperthyroidism/Thyrotoxicosis, Hyperthyroidism; Goiter, Iodine Induced Thyrotoxicosis, Contrast Media Adverse Reaction, Thyrotoxicosis of Other Specified Origin
- Keywords
- Hyperthyroidism, Iodinated contrast media, Euthyroid goiter, Thyroid nodules, Thyroid volume, Thiamazole, Sodium perchlorate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- National Institute of Cardiology, Warsaw, Poland
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 11 Mar 2020 (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.
The proper synthesis of thyroid hormones is dependent on adequate iodine supply. The mean daily iodine intake recommended by World Health Organization is 150 mg. Iodinated contrast medium (ICM) typically contains 13 500 mg of free iodine and 15-60 g of bound iodine, an amount well above acceptable upper level. In a situation of excess iodine, thyroid discontinues the release of hormones (Wolff-Chaikoff effect), which is usually transient, although can persist causing hypothyroidism. Iodine-induced hyperthyroidism (IIH), known as the Jod-Basedow phenomenon is infrequent, but elderly patients and individuals with autonomously functioning nodular goiters are at higher risk of developing this dysfunction. According to recent studies the risk of ICM-induced hyperthyroidism appears to be low. The prevalence has not been well assessed and varies from 1 % to 10 %. Currently, there are no specific guidelines concerning the prophylactic therapy of IIH. American Thyroid Association (ATA) does not recommend routine administration of antithyroid drugs before iodinated contrast medium for all patients, however, advises to consider prophylaxis in patients at high risk of developing IIH or with cardiovascular comorbidities. ATA recommends avoidance of additional iodine and administration of b-blockers alone or with antithyroid drugs as a treatment of IIH, depending on the severity of hyperthyroidism.
This study was performed to evaluate the influence of ICM on thyroid status and advantages of prophylactic therapy during ICM exposure in patients with euthyroid goiter and cardiovascular comorbidities. The association between the incidence of IIH and thyroid volume was also assessed.
Detailed description
Patients were divided into two subsets on the basis of received prophylactic therapy. Group with prophylaxis (13 patients) received thiamazole alone (7 patients) or with sodium perchlorate (6 patients). The prophylaxis was administered one day prior to iodinated contrast medium (ICM) and for at least 14 days after ICM for thiamazole (20-40 mg/daily) and 10 days after ICM for sodium perchlorate (900 mg/daily). Group without prophylaxis (23 patients) received no prophylactic treatment. Laboratory tests were performed before and after ICM injection in all patients from both evaluated groups. Each individual had TSH and creatinine level measured at baseline. The investigators analyzed clinical data such as age, sex, mean volume of contrast media, goiter size and patients' comorbidities. Levels of TSH, FT3 and FT4 were evaluated retrospectively at different points in time after ICM. Ultrasonography was performed in each patient to assess thyroid morphology. The investigators performed a comparison between both groups in regard to duration of overt hyperthyroidism and thiamazole treatment. Thyroid volume was compared between patients who developed hyperthyroidism after ICM injection and remained euthyroid after ICM injection. Patients diagnosed with overt hyperthyroidism were treated with thiamazole.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with prophylaxis | – | Procedure: Administration of iodinated contrast media, Drug: Prophylactic administration of antithyroid drugs before iodinated contrast media exposureGroup of 13 patients with euthyroid goiter who received prophylactic treatment before and after iodinated contrast medium (ICM) injection. 6 patients received thiamazole with sodium perchlorate, one day prior to ICM and for at least 14 days after for thiamazole (20-40 mg/daily) and 10 days after for sodium perchlorate (900 mg/daily). 7 patients received only thiamazole as prophylactic treatment due to lack of sodium perchlorate at the time. |
| Group without prophylaxis | – | Procedure: Administration of iodinated contrast mediaGroup of 23 patients with euthyroid goiter who received no prophylactic treatment before iodinated contrast medium injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 36 patients (15 males) with euthyroid goiter and cardiovascular comorbidities admitted to the Institute of Cardiology between January 2015 and November 2019. The median age of treated patients was 68 years old.
Key inclusion criteria (4 listed)
- euthyroidism at baseline (defined as TSH level within the reference range)
- diffuse or multinodular goiter
- iodinated contrast media (ICM) exposure
- time of observation after ICM exposure longer than 4 weeks
Key exclusion criteria (2 listed)
- Graves' disease
- administration of thyroid hormones, glucocorticoids, iodine-containing medications or iodine contrast agent 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 |
|---|---|---|
| Administration of iodinated contrast mediaEach patient was exposed on iodinated contrast medium administered during computed tomography, coronary angiography or transcatheter aortic valve implantation. | Procedure or surgery | Group with prophylaxis, Group without prophylaxis |
| Prophylactic administration of antithyroid drugs before iodinated contrast media exposure13 patients received thiamazole with (6 patients) or without (7 patients) sodium perchlorate, one day prior to iodinated contrast medium (ICM) and for at least 14 days after for thiamazole (20-40 mg/daily) and 10 days after for sodium perchlorate (900 mg/daily). | Drug | Group with prophylaxis |
Primary outcome
Influence of iodinated contrast medium administration on thyroid function.
Time frame: up to 72 weeks
Evaluation of TSH, FT3 and FT4 levels at different points in time after iodinated contrast medium injection. Normal thyroid function was defined as TSH levels between 0.27 and 4.20 mIU/L. The reference range for fT4 and fT3 was 0.93-1.7 ng/dl and 2.0-4.4 pg/ml, respectively.
Evaluation of the association between the incidence of iodine-induced hyperthyroidism and thyroid volume.
Time frame: up to 72 weeks
Analysis of association between thyroid volume and changes in thyroid status after iodinated contrast medium injection. Normal thyroid function was defined as TSH levels between 0.27 and 4.20 mIU/L. The reference range for fT4 and fT3 was 0.93-1.7 ng/dl and 2.0-4.4 pg/ml, respectively. Subclinical hyperthyroidism was diagnosed on the basis of suppressed TSH and normal fT4 and fT3 values. Overt hyperthyroidism was defined as TSH level below lower limit and elevated fT4 and/or fT3 concentrations. Ultrasonography was performed in each patient to assess thyroid volume [ml]. Enlargement of the gland was defined as a volume exceeding 18 ml in females and 25 ml in males.
Evaluation of the association between the incidence of iodine-induced hyperthyroidism and the use of prophylactic treatment with antithyroid drugs before and after iodinated-contrast medium injection.
Time frame: up to 72 weeks
Evaluation of TSH, FT3 and FT4 levels at different points in time after iodinated contrast medium injection and comparison between groups. Normal thyroid function was defined as TSH levels between 0.27 and 4.20 mIU/L. The reference range for fT4 and fT3 was 0.93-1.7 ng/dl and 2.0-4.4 pg/ml, respectively. Subclinical hyperthyroidism was diagnosed on the basis of suppressed TSH and normal fT4 and fT3 values. Overt hyperthyroidism was defined as TSH level below lower limit and elevated fT4 and/or fT3 concentrations.
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 11 Mar 2020.
- Individual participant dataSharing planned: Yes. The collected data will be shared in a publication.
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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.
Piotr Miśkiewicz, MD, PhD principal investigator
Department of Endocrinology Medical University of Warsaw
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyroidism/Thyrotoxicosis and Hyperthyroidism; Goiter, run by Medical University of Warsaw.
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 4 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: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Influence of iodinated contrast medium administration on thyroid function. (time frame: up to 72 weeks). The study lists 3 primary outcomes in all. 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 11 Mar 2020; AzTrials last refreshed its copy on 28 Oct 2026.