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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Syncope; Seizures
• Intervention / Treatment: Diagnostic test: Evalution of thyroid function

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Matthias Sczesny-Kaiser, M.D.; Phone Number: +49-234-302; Email: matthias.sczesny-kaiser@bergmannsheil.de

Study Locations

• Germany
  • NRW
    • Bochum, NRW, Germany, D-44789
      • Active, not recruiting
      • Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
    • Bochum, NRW, Germany, D-44789
      • Recruiting
      • Medical Hospital I, Bergmannsheil University Hospitals, Ruhr University of Bochum
      • Contact: Johannes W Dietrich, M.D.; Phone Number: 6400 +49-234-302; Email: johannes.dietrich@rub.de
      • Contact: Jennifer N Siekira; Phone Number: 6400 +49-234-302; Email: jennifer.siekira@bergmannsheil.de
      • Principal Investigator: Jennifer N Siekira
      • Sub-Investigator: Saska Milosavljeciv
      • Sub-Investigator: Viktoria Stab, PhD
    • Bochum, NRW, Germany, D-44789
      • Recruiting
      • Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum
      • Contact: Assem Aweimer, M.D.; Phone Number: +49-234-302; Email: assem.aweimer@ruhr-uni-bochum.de
    • Bochum, NRW, Germany, D-44789
      • Recruiting
      • Neurological University Hospital and Clinics, Bergmannsheil University Hospitals, Ruhr University of Bochum
      • Contact: Matthias Sczesny-Kaiser, M.D.; Email: matthias.sczesny-kaiser@rub.de
      • Principal Investigator: Matthias Sczesny-Kaiser, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible are subjects addmitted for in-patient treatment after syncope or cerebral seicure

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Syncope; Subjects admitted immediately after syncopation.	Diagnostic test: Evalution of thyroid function; Determination of TSH, free T4, free T3, SPINA-GT, SPINA-GD and Jostel's TSH index
Seizre; Subject admitted immediately after cerebarl seizure	Diagnostic test: Evalution of thyroid function; Determination of TSH, free T4, free T3, SPINA-GT, SPINA-GD and Jostel's TSH index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Collaborators: Bergmannsheil University Hospitals

Publications and helpful links

General Publications

• 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.
• Aweimer A, El-Battrawy I, Akin I, Borggrefe M, Mugge 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.
• 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.
• 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.
• Dietrich JW, Muller P, Schiedat F, Schlomicher M, Strauch J, Chatzitomaris A, Klein HH, Mugge A, Kohrle 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.
• Dietrich JW, Hoermann R, Midgley JEM, Bergen F, Muller 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.
• 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.
• Goldstein DS. Adrenal responses to stress. Cell Mol Neurobiol. 2010 Nov;30(8):1433-40. doi: 10.1007/s10571-010-9606-9.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2021
• Primary Completion (ANTICIPATED): May 13, 2023
• Study Completion (ANTICIPATED): May 13, 2024

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (ACTUAL): May 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: syncope; seizure; TACITUS; loss of consciousness; thyroid allostasis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Seizures; Syncope
• Other Study ID Numbers: 21-7171; DRKS00025266 (REGISTRY: DRKS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymised data may be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No