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

Sponsor
Ruhr University of Bochum (Other)
Overall Status
Recruiting
CT.gov ID
NCT04879147
Collaborator
Bergmannsheil University Hospitals (Other)
350
4
36.3
87.5
2.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure (Thyro-Syncope)
Actual Study Start Date :
May 5, 2021
Anticipated Primary Completion Date :
May 13, 2023
Anticipated Study Completion Date :
May 13, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Prevalence of allostatic responses of thyroid function after short-term loss of consciousness [2 hours]

    Prevalence of increased TSH immediately after syncope or seizure

Secondary Outcome Measures

  1. Time series of thyroid function after short-term loss of consciousness [72 hours]

    Temporal evolution of TSH and thyroid hormone concentration during three days after syncope or seicure

  2. Diagnostic value of TSH after short-term loss of consciousness [72 hours]

    Sensitivity, specificitay and likelihood ratios of TSH compared to free T4 and free T3 after syncopation or seizure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum Bochum NRW Germany D-44789
2 Medical Hospital I, Bergmannsheil University Hospitals, Ruhr University of Bochum Bochum NRW Germany D-44789
3 Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum Bochum NRW Germany D-44789
4 Neurological University Hospital and Clinics, Bergmannsheil University Hospitals, Ruhr University of Bochum Bochum NRW Germany D-44789

Sponsors and Collaborators

  • Ruhr University of Bochum
  • Bergmannsheil University Hospitals

Investigators

  • Principal Investigator: Johannes W Dietrich, M.D., Bergmannsheil University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
PD Dr. Johannes W. Dietrich, MD, Consultant Endocrinologist, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT04879147
Other Study ID Numbers:
  • 21-7171
  • DRKS00025266
First Posted:
May 10, 2021
Last Update Posted:
May 21, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by PD Dr. Johannes W. Dietrich, MD, Consultant Endocrinologist, Ruhr University of Bochum
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 21, 2021