Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure (Thyro-Syncope)

Ruhr University of Bochum

Status: Unknown

Conditions: Seizures; Syncope

Treatments: Diagnostic Test: Evalution of thyroid function

Study type: Observational

Funder types: Other

Identifiers

NCT04879147

DRKS00025266 (Registry Identifier)

21-7171

Details and patient eligibility

About

Changes of thyroid function may occur after short loss of consciousness, but they haven't been systematically evaluated up to now, although occasional observations suggest temporal increases in TSH concentration.

This study aims at assessing transient changes of biomarkers of thyroid function after syncopation and seizure.

Results of the study might contribute to an improved detection rate of thyrotoxicosis.

Full description

Transient allostatic responses of thyroid function have been described in critical illness. Own observations suggest similar reactive responses after syncopation and cerebral seizures. They are marked especially by increased concentration of serum thyrotropin (TSH), suggesting a type 2 allostatic response. However, changes of thyroid function after temporal loss of consciousness haven't been systematically evaluated up to now. Current diagnostic guidelines recommend primarily the determination of serum TSH concentration for screening of thyroid function, and the measurement of peripheral thyroid hormones (T4 and/or T3) is only recommended if TSH determination results in pathological values. This TSH reflex strategy may be misleading after short-term loss of consciousness.

This study aims at assessing the prevalence of allostatic responses of thyroid function after events of syncopation or seizure and at investigating the consecutive temporal development of biomarkers of thyroid function. An additional aim includes the diagnostic value of TSH determination, compared to measurement of free thyroid hormones, for thyroid dysfunction after syncopation or seizure.

Results of this study might contribute to an improved detection rate of thyrotoxicosis. In cases of medical emergencies and in-patient treatment interventions with a significant iodine load are common, including the application of iodinated radiocontrast agents and amiodarone. In this setting, undetected hyperthyroidism may lead to thyroid storm, which is associated with a high mortality.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admission after syncope or seizure
• Age of 18 years or older
• First bleed not later than two hours after event (syncope or seizure)
• Written informed consent obtained

Exclusion criteria

• Results of thyroid hormones not available within two hours after event
• Pituitary dysfunction
• Thyroid dysfunction
• Use of iodinated radiocontrast agents less than three months ago
• Therapy with amiodarone in the previous three years
• Pregnancy

Trial design

350 participants in 2 patient groups

Syncope

Description:

Subjects admitted immediately after syncopation.

Treatment:

Diagnostic Test: Evalution of thyroid function

Seizre

Description:

Subject admitted immediately after cerebarl seizure

Treatment:

Diagnostic Test: Evalution of thyroid function