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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-05

Study Completion Date

2024-05-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Syncope Seizures

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Syncope

Subjects admitted immediately after syncopation.

Evalution of thyroid function

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bergmannsheil University Hospitals

UNKNOWN

Sponsor Role collaborator

Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Johannes W. Dietrich, MD

Consultant Endocrinologist

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status ACTIVE_NOT_RECRUITING

Medical Hospital I, Bergmannsheil University Hospitals, Ruhr University of Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status RECRUITING

Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status RECRUITING

Neurological University Hospital and Clinics, Bergmannsheil University Hospitals, Ruhr University of Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Johannes W Dietrich, M.D.

Role: CONTACT

+49-234-302 ext. 6400

Matthias Sczesny-Kaiser, M.D.

Role: CONTACT

+49-234-302 ext. 0

Facility Contacts

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Johannes W Dietrich, M.D.

Role: primary

+49-234-302 ext. 6400

Jennifer N Siekira

Role: backup

+49-234-302 ext. 6400

Assem Aweimer, M.D.

Role: primary

+49-234-302 ext. 0

Matthias Sczesny-Kaiser, M.D.

Role: primary

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.

Reference Type BACKGROUND
PMID: 33179374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28775711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18851740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26279999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27375554 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33193077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32349628 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 21061156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33585528 (View on PubMed)

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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