Iodinated Contrast Media Induced Hyperthyroidism

NCT04304794 | Completed

• 1 other identifier: ICMThyro
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  up to 72 weeks

Study Arms (2)

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.

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.

Procedure: Administration of iodinated contrast media

Interventions

Administration of iodinated contrast media PROCEDURE

Each patient was exposed on iodinated contrast medium administered during computed tomography, coronary angiography or transcatheter aortic valve implantation.

Group with prophylaxis; Group without prophylaxis

Prophylactic administration of antithyroid drugs before iodinated contrast media exposure DRUG

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).

Group with prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Graves' disease
• administration of thyroid hormones, glucocorticoids, iodine-containing medications or iodine contrast agent within the past 6 months

Sponsors & Collaborators

• Medical University of Warsaw: lead
• National Institute of Cardiology, Warsaw, Poland: collaborator

MeSH Terms

Conditions

Hyperthyroidism; Thyrotoxicosis; Goiter; Euthyroid Goiter; Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Piotr Miśkiewicz, MD, PhD

  Department of Endocrinology Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 11, 2020
• Study Start: January 2, 2015
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share