Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure
NCT ID: NCT04879147
Last Updated: 2021-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
350 participants
OBSERVATIONAL
2021-05-05
2024-05-13
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Syncope
Subjects admitted immediately after syncopation.
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
Evalution of thyroid function
Determination of TSH, free T4, free T3, SPINA-GT, SPINA-GD and Jostel's TSH index
Interventions
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Evalution of thyroid function
Determination of TSH, free T4, free T3, SPINA-GT, SPINA-GD and Jostel's TSH index
Eligibility Criteria
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Inclusion Criteria
* Age of 18 years or older
* First bleed not later than two hours after event (syncope or seizure)
* Written informed consent obtained
Exclusion Criteria
* Pituitary dysfunction
* Thyroid dysfunction
* Use of iodinated radiocontrast agents less than three months ago
* Therapy with amiodarone in the previous three years
* Pregnancy
18 Years
ALL
No
Sponsors
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Bergmannsheil University Hospitals
UNKNOWN
Ruhr University of Bochum
OTHER
Responsible Party
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PD Dr. Johannes W. Dietrich, MD
Consultant Endocrinologist
Principal Investigators
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Johannes W Dietrich, M.D.
Role: PRINCIPAL_INVESTIGATOR
Bergmannsheil University Hospitals
Locations
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Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
Bochum, North Rhine-Westphalia, Germany
Medical Hospital I, Bergmannsheil University Hospitals, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, Germany
Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, Germany
Neurological University Hospital and Clinics, Bergmannsheil University Hospitals, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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, 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.
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.
Other Identifiers
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DRKS00025266
Identifier Type: REGISTRY
Identifier Source: secondary_id
21-7171
Identifier Type: -
Identifier Source: org_study_id
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