CClinicalTrials.gg
Status unknownNCT04879147Thyro-SyncopeUpdated May 21, 2021

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

An observational study in Syncope and Seizures, sponsored by Ruhr University of Bochum. Status unknown at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-21.

Sponsored by Ruhr University of Bochum · Observational

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
350
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Syncope
  • Seizures

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Keywords

  • thyroid allostasis
  • TACITUS
  • syncope
  • seizure
  • loss of consciousness
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In context

Seizures

881 studies on the registry are indexed under Seizures; 143 are open to participants now.

This study's planned enrollment of 350 is above the median of 150 across 235 observational studies indexed under Seizures.

Browse Seizures studies →

Lead sponsor

Ruhr University of Bochum is the lead sponsor of 124 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
350 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Syncope

    Subjects admitted immediately after syncopation.

    Diagnostic Test: Evalution of thyroid function

  • Seizre

    Subject admitted immediately after cerebarl seizure

    Diagnostic Test: Evalution of thyroid function

Interventions

  • Diagnostic testEvalution of thyroid function

    Determination of TSH, free T4, free T3, SPINA-GT, SPINA-GD and Jostel's TSH index

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What researchers measure

Primary outcomes

  1. Prevalence of allostatic responses of thyroid function after short-term loss of consciousness

    Prevalence of increased TSH immediately after syncope or seizure

    Time frame: 2 hours

Secondary outcomes

  1. 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

    Time frame: 72 hours

  2. 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

    Time frame: 72 hours

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Study locations

3 of 4 sites recruiting
  • Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
    Bochum, NRW D-44789, Germany
    Active, not recruiting
  • Medical Hospital I, Bergmannsheil University Hospitals, Ruhr University of Bochum
    Bochum, NRW D-44789, Germany
    • Johannes W Dietrich, M.D. · Contact · johannes.dietrich@rub.de · +49-234-302
    • Jennifer N Siekira · Contact · jennifer.siekira@bergmannsheil.de · +49-234-302
    • Johannes W Dietrich, M.D. · Principal investigator
    • Jennifer N Siekira · Principal investigator
    • Saska Milosavljeciv · Sub investigator
    • Viktoria Stab, PhD · Sub investigator
    • Christine Fischer-Lahdo · Sub investigator
    Recruiting
  • Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum
    Bochum, NRW D-44789, Germany
    Recruiting
  • Neurological University Hospital and Clinics, Bergmannsheil University Hospitals, Ruhr University of Bochum
    Bochum, NRW D-44789, Germany
    Recruiting
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References and documents

Publications

  • 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. PubMed 33179374 ↗
  • 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. PubMed 28775711 ↗
  • 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. PubMed 18851740 ↗
  • 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. PubMed 26279999 ↗
  • 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. PubMed 27375554 ↗
  • 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. PubMed 33193077 ↗
  • 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. PubMed 32349628 ↗
  • Goldstein DS. Adrenal responses to stress. Cell Mol Neurobiol. 2010 Nov;30(8):1433-40. doi: 10.1007/s10571-010-9606-9. PubMed 21061156 ↗
  • 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. PubMed 33585528 ↗

Individual participant data

Plan to share: Undecided — Anonymised data may be shared upon request.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04879147
Lead sponsor
Ruhr University of Bochum
Collaborators
Bergmannsheil University Hospitals
Responsible party
PD Dr. Johannes W. Dietrich, MD (Consultant Endocrinologist, Ruhr University of Bochum) — Principal investigator
First posted
May 10, 2021
Start date
May 5, 2021
Primary completion
May 13, 2023 (estimated)
Completion
May 13, 2024 (estimated)
Last update
May 21, 2021

Study contacts

Johannes W Dietrich, M.D.
Contact
johannes.dietrich@ruhr-uni-bochum.de
+49-234-302 ext. 6400
Matthias Sczesny-Kaiser, M.D.
Contact
matthias.sczesny-kaiser@bergmannsheil.de
+49-234-302 ext. 0
Johannes W Dietrich, M.D.
principal investigator · Bergmannsheil University Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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