Trial Outcomes & Findings for Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure (NCT NCT02766283)
NCT ID: NCT02766283
Last Updated: 2018-03-26
Results Overview
Recruitment status
COMPLETED
Target enrollment
843 participants
Primary outcome timeframe
Up to one year after iodinated contrast material (ICM) exposure (828 person years)
Results posted on
2018-03-26
Participant Flow
This study was a retrospective cohort study, using the data from the years 1998 until 2015 in the database of Maccabi Health Services (Israel).
Between 1.1.1998 and 31.12.2015, 877 participants were identified. After applying exclusion criteria, 34 participants were excluded from the initial cohort and the final cohort consisted of 843 participants.
Participant milestones
| Measure |
Iodine Contrast Agent
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: thyroid-stimulating hormone (TSH) levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
|---|---|
|
Overall Study
STARTED
|
843
|
|
Overall Study
COMPLETED
|
816
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Iodine Contrast Agent
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: thyroid-stimulating hormone (TSH) levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
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|---|---|
|
Overall Study
Lost to Follow-up
|
27
|
Baseline Characteristics
Participants in final cohort who underwent the 2nd examination
Baseline characteristics by cohort
| Measure |
Iodine Contrast Agent
n=843 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
|---|---|
|
Age, Continuous
|
1.06 Years
STANDARD_DEVIATION 0.87 • n=843 Participants
|
|
Sex: Female, Male
Female
|
382 Participants
n=843 Participants
|
|
Sex: Female, Male
Male
|
461 Participants
n=843 Participants
|
|
Weight
|
8.80 Kilograms
STANDARD_DEVIATION 3.39 • n=843 Participants
|
|
Comorbidity
Cardio
|
495 Participants
n=843 Participants
|
|
Comorbidity
Diabetes
|
1 Participants
n=843 Participants
|
|
Comorbidity
Cancer
|
21 Participants
n=843 Participants
|
|
Comorbidity
Overweight
|
12 Participants
n=843 Participants
|
|
Sum of Examinations
1
|
775 Participants
n=843 Participants
|
|
Sum of Examinations
>= 2
|
68 Participants
n=843 Participants
|
|
Type of 1st examination
Cardio-angiography
|
481 Participants
n=843 Participants
|
|
Type of 1st examination
CT
|
362 Participants
n=843 Participants
|
|
Type of >=2nd examination
Cardio-angiography
|
47 Participants
n=68 Participants • Participants in final cohort who underwent the 2nd examination
|
|
Type of >=2nd examination
CT
|
21 Participants
n=68 Participants • Participants in final cohort who underwent the 2nd examination
|
|
Time between examinations
First and second
|
282.79 Days
STANDARD_DEVIATION 252.34 • n=843 Participants
|
|
Time between examinations
Second and third
|
208.19 Days
STANDARD_DEVIATION 180.01 • n=843 Participants
|
|
Time between examinations
Third and fourth
|
212.00 Days
STANDARD_DEVIATION 196.28 • n=843 Participants
|
|
Dispenses of hypothyroidism inducing drugs
Anticonvulsants
|
21 Participants
n=843 Participants
|
|
Dispenses of hypothyroidism inducing drugs
Amiodarone
|
5 Participants
n=843 Participants
|
PRIMARY outcome
Timeframe: Up to one year after iodinated contrast material (ICM) exposure (828 person years)Population: Final Cohort
Outcome measures
| Measure |
Iodine Contrast Agent
n=843 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to one year after ICM exposure (828 person years)Population: Final Cohort
Outcome measures
| Measure |
Iodine Contrast Agent
n=832 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
n=11 Participants
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort
Male
|
454 Participants
|
7 Participants
|
|
Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort
Female
|
378 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At first examinationPopulation: Final Cohort
Outcome measures
| Measure |
Iodine Contrast Agent
n=832 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
n=11 Participants
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort
|
1.07 Years
Standard Deviation 0.86
|
0.53 Years
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Within a range of ±360 days of the first examinationPopulation: Final Cohort
Outcome measures
| Measure |
Iodine Contrast Agent
n=832 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
n=11 Participants
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort
|
8.84 Kilograms
Standard Deviation 3.37
|
6.57 Kilograms
Standard Deviation 3.74
|
SECONDARY outcome
Timeframe: Prior to first examinationPopulation: Final Cohort
Outcome measures
| Measure |
Iodine Contrast Agent
n=832 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
n=11 Participants
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort
Cardio
|
485 Participants
|
10 Participants
|
|
Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort
Diabetes
|
1 Participants
|
0 Participants
|
|
Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort
Cancer
|
21 Participants
|
0 Participants
|
|
Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort
Overweight
|
12 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to one year after ICM exposure (828 person years)Population: Final Cohort
Outcome measures
| Measure |
Iodine Contrast Agent
n=832 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
n=11 Participants
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without
1
|
765 Participants
|
10 Participants
|
|
Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without
>=2
|
67 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to one year after ICM exposure (828 person years)Population: Final Cohort
Outcome measures
| Measure |
Iodine Contrast Agent
n=832 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
n=11 Participants
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without
Cardio-angiography
|
471 Participants
|
10 Participants
|
|
Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without
CT
|
361 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to one year after ICM exposure (828 person years)Population: Final Cohort
Outcome measures
| Measure |
Iodine Contrast Agent
n=832 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
n=11 Participants
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without
Cardio-angiography
|
46 Participants
|
1 Participants
|
|
Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without
CT
|
21 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to one year after ICM exposure (828 person years)Population: Final Cohort
Outcome measures
| Measure |
Iodine Contrast Agent
n=832 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
n=11 Participants
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without
First and second
|
282.72 Days
Standard Deviation 254.24
|
288 Days
Standard Deviation NA
Only one participants underwent the second examination among the cases with an hypothyroidism indication
|
|
Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without
Second and third
|
208.19 Days
Standard Deviation 180.01
|
—
|
|
Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without
Third and fourth
|
212.00 Days
Standard Deviation 196.28
|
—
|
SECONDARY outcome
Timeframe: Up to one year after ICM exposure (828 person years)Population: Final Cohort
Outcome measures
| Measure |
Iodine Contrast Agent
n=828 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism
|
76.54 Days
Standard Deviation 93.05
|
—
|
SECONDARY outcome
Timeframe: Up to one year after ICM exposure (828 person years)Population: Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.
Based on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below.
Outcome measures
| Measure |
Iodine Contrast Agent
n=8 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
Case number 2
|
NA Months
Thyroid replacement therapy was dispensed
|
—
|
|
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
Case number 3
|
2 Months
|
—
|
|
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
Case number 6
|
NA Months
Thyroid replacement therapy was dispensed
|
—
|
|
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
Case number 10
|
2 Months
|
—
|
SECONDARY outcome
Timeframe: Up to one year after ICM exposure (828 person years)Population: Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.
Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.
Outcome measures
| Measure |
Iodine Contrast Agent
n=8 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
Case number 4
|
4 Months
|
—
|
|
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
Case number 7
|
10 Months
|
—
|
SECONDARY outcome
Timeframe: Up to one year after ICM exposure (828 person years)Population: Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.
Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.
Outcome measures
| Measure |
Iodine Contrast Agent
n=8 Participants
The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy.
|
Hypothyroidism Indication
Participants with potential hypothyroidism detected during the one-year follow up period (828 person years)
|
|---|---|---|
|
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
Case number 5
|
14 Days
|
—
|
|
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category
Case number 11
|
8 Days
|
—
|
Adverse Events
Iodine Contrast Agent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER