Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure

Seizures Clinical Trial

— Thyro-Syncope  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879147
• Other study ID #: 21-7171
• Secondary ID: DRKS00025266
• Status: Recruiting
• Start date: May 5, 2021
• Est. completion date: May 13, 2024

Study information

• Verified date: May 2021
• Source: Ruhr University of Bochum
• Contact: Johannes W Dietrich, M.D.
• Phone: +49-234-302
• Email: johannes.dietrich[@]ruhr-uni-bochum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Seizures
• Syncope

Intervention

Diagnostic Test:
• Evalution of thyroid function
Determination of TSH, free T4, free T3, SPINA-GT, SPINA-GD and Jostel's TSH index

Locations

Country	Name	City	State
Germany	Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum	Bochum	NRW
Germany	Medical Hospital I, Bergmannsheil University Hospitals, Ruhr University of Bochum	Bochum	NRW
Germany	Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum	Bochum	NRW
Germany	Neurological University Hospital and Clinics, Bergmannsheil University Hospitals, Ruhr University of Bochum	Bochum	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Ruhr University of Bochum	Bergmannsheil University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (9)

Aweimer A, El-Battrawy I, Akin I, Borggrefe M, Mügge A, Patsalis PC, Urban A, Kummer M, Vasileva S, Stachon A, Hering S, Dietrich JW. Abnormal thyroid function is common in takotsubo syndrome and depends on two distinct mechanisms: results of a multicentre observational study. J Intern Med. 2021 May;289(5):675-687. doi: 10.1111/joim.13189. Epub 2020 Nov 12. — View Citation

Chatzitomaris A, Hoermann R, Midgley JE, Hering S, Urban A, Dietrich B, Abood A, Klein HH, Dietrich JW. Thyroid Allostasis-Adaptive Responses of Thyrotropic Feedback Control to Conditions of Strain, Stress, and Developmental Programming. Front Endocrinol (Lausanne). 2017 Jul 20;8:163. doi: 10.3389/fendo.2017.00163. eCollection 2017. Review. — View Citation

Dietrich JW, Hoermann R, Midgley JEM, Bergen F, Müller P. The Two Faces of Janus: Why Thyrotropin as a Cardiovascular Risk Factor May Be an Ambiguous Target. Front Endocrinol (Lausanne). 2020 Oct 26;11:542710. doi: 10.3389/fendo.2020.542710. eCollection 2020. — View Citation

Dietrich JW, Landgrafe-Mende G, Wiora E, Chatzitomaris A, Klein HH, Midgley JE, Hoermann R. Calculated Parameters of Thyroid Homeostasis: Emerging Tools for Differential Diagnosis and Clinical Research. Front Endocrinol (Lausanne). 2016 Jun 9;7:57. doi: 10.3389/fendo.2016.00057. eCollection 2016. — View Citation

Dietrich JW, Müller P, Schiedat F, Schlömicher M, Strauch J, Chatzitomaris A, Klein HH, Mügge A, Köhrle J, Rijntjes E, Lehmphul I. Nonthyroidal Illness Syndrome in Cardiac Illness Involves Elevated Concentrations of 3,5-Diiodothyronine and Correlates with Atrial Remodeling. Eur Thyroid J. 2015 Jun;4(2):129-37. doi: 10.1159/000381543. Epub 2015 May 23. — View Citation

Dietrich JW, Stachon A, Antic B, Klein HH, Hering S. The AQUA-FONTIS study: protocol of a multidisciplinary, cross-sectional and prospective longitudinal study for developing standardized diagnostics and classification of non-thyroidal illness syndrome. BMC Endocr Disord. 2008 Oct 13;8:13. doi: 10.1186/1472-6823-8-13. — View Citation

Fitzgerald SP, Bean NG, Falhammar H, Tuke J. Clinical Parameters Are More Likely to Be Associated with Thyroid Hormone Levels than with Thyrotropin Levels: A Systematic Review and Meta-Analysis. Thyroid. 2020 Dec;30(12):1695-1709. doi: 10.1089/thy.2019.0535. Epub 2020 Jun 4. — View Citation

Goldstein DS. Adrenal responses to stress. Cell Mol Neurobiol. 2010 Nov;30(8):1433-40. doi: 10.1007/s10571-010-9606-9. — View Citation

Stanculescu D, Larsson L, Bergquist J. Hypothesis: Mechanisms That Prevent Recovery in Prolonged ICU Patients Also Underlie Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Front Med (Lausanne). 2021 Jan 28;8:628029. doi: 10.3389/fmed.2021.628029. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of allostatic responses of thyroid function after short-term loss of consciousness	Prevalence of increased TSH immediately after syncope or seizure	2 hours
Secondary	Time series of thyroid function after short-term loss of consciousness	Temporal evolution of TSH and thyroid hormone concentration during three days after syncope or seicure	72 hours
Secondary	Diagnostic value of TSH after short-term loss of consciousness	Sensitivity, specificitay and likelihood ratios of TSH compared to free T4 and free T3 after syncopation or seizure	72 hours