SyncopeThyro-SyncopeNCT04879147
Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure
An observational study of Syncope and Seizures, run by Ruhr University of Bochum at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Evalution of thyroid function
- How many people
- 350 participants
- Where
- 4 sitesGermany
- Study dates
- 5 May 2021to 13 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Eligible are subjects addmitted for in-patient treatment after syncope or cerebral seicure
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites, 3 recruiting
- Active, not recruiting
Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
Bochum, North Rhine-Westphalia, D-44789
- Recruiting
Medical Hospital I, Bergmannsheil University Hospitals, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, D-44789
Johannes W Dietrich, M.D., +49-234-302 ext. 6400, johannes.dietrich@rub.de
Jennifer N Siekira, +49-234-302 ext. 6400, jennifer.siekira@bergmannsheil.de
- Recruiting
Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, D-44789
Assem Aweimer, M.D., +49-234-302 ext. 0, assem.aweimer@ruhr-uni-bochum.de
- Recruiting
Neurological University Hospital and Clinics, Bergmannsheil University Hospitals, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, D-44789
Matthias Sczesny-Kaiser, M.D., matthias.sczesny-kaiser@rub.de
Matthias Sczesny-Kaiser, M.D.
About this study
Official title: 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.
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.
- Being tested
- Evalution of thyroid function
- Keywords
- thyroid allostasis, TACITUS, syncope, seizure, loss of consciousness
- Medical subject headings
- Syncope, Seizures, Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evalution of thyroid functionDiagnostic test
Determination of TSH, free T4, free T3, SPINA-GT, SPINA-GD and Jostel's TSH index
| Study group | Role | What they receive |
|---|---|---|
| Syncope | Subjects admitted immediately after syncopation. Receives: Diagnostic Test: Evalution of thyroid function | |
| Seizre | Subject admitted immediately after cerebarl seizure Receives: Diagnostic Test: Evalution of thyroid function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of allostatic responses of thyroid function after short-term loss of consciousness
Prevalence of increased TSH immediately after syncope or seizure
Measured: 2 hours
Secondary outcomes (2)
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
Measured: 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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start5 May 2021
- Primary completion13 May 2023 (estimated)
- Study completion13 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Bergmannsheil University Hospitals
- Responsible party
- Principal investigator, PD Dr. Johannes W. Dietrich, MD, Ruhr University of Bochum
- Investigators
- Johannes W Dietrich, M.D., Principal investigator, Bergmannsheil University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879147
- Sponsor's protocol ID
- 21-7171
- Other IDs
- DRKS00025266
- Acronym
- Thyro-Syncope
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data may be shared upon request.
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 33179374Chatzitomaris 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 28775711Dietrich 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 18851740Dietrich 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 26279999Dietrich 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 27375554Dietrich 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 33193077Fitzgerald 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 32349628Goldstein DS. Adrenal responses to stress. Cell Mol Neurobiol. 2010 Nov;30(8):1433-40. doi: 10.1007/s10571-010-9606-9.
PubMed 21061156Stanculescu 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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Syncopation and Seizure (Thyro-Syncope)
- ClinicalTrials.gov ID
- NCT04879147
- Acronym / sponsor ID
- Thyro-Syncope / 21-7171
- Keywords
- thyroid allostasis, TACITUS, syncope, seizure, loss of consciousness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Bergmannsheil University Hospitals
- Study start
- 5 May 2021 (actual)
- Primary completion
- 13 May 2023 (estimated)
- Study completion
- 13 May 2024 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Syncope | – | Diagnostic Test: Evalution of thyroid functionSubjects admitted immediately after syncopation. |
| Seizre | – | Diagnostic Test: Evalution of thyroid functionSubject admitted immediately after cerebarl seizure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible are subjects addmitted for in-patient treatment after syncope or cerebral seicure
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evalution of thyroid functionDetermination of TSH, free T4, free T3, SPINA-GT, SPINA-GD and Jostel's TSH index | Diagnostic test | Seizre, Syncope |
Primary outcome
Prevalence of allostatic responses of thyroid function after short-term loss of consciousness
Time frame: 2 hours
Prevalence of increased TSH immediately after syncope or seizure
2 secondary outcomes
Time series of thyroid function after short-term loss of consciousness
Time frame: 72 hours
Diagnostic value of TSH after short-term loss of consciousness
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Background: PubMed 33179374Aweimer 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.
- Background: PubMed 28775711Chatzitomaris 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.
- Background: PubMed 18851740Dietrich 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.
- Background: PubMed 26279999Dietrich 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.
- Background: PubMed 27375554Dietrich 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.
- Background: PubMed 33193077Dietrich 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.
- Background: PubMed 32349628Fitzgerald 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.
- Background: PubMed 21061156Goldstein DS. Adrenal responses to stress. Cell Mol Neurobiol. 2010 Nov;30(8):1433-40. doi: 10.1007/s10571-010-9606-9.
- Background: PubMed 33585528Stanculescu 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.
- Individual participant dataSharing planned: Undecided. Anonymised data may be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes W Dietrich, M.D. principal investigator
Bergmannsheil University Hospitals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Seizures, run by Ruhr University of Bochum at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes W Dietrich, M.D. (+49-234-302 ext. 6400, johannes.dietrich@ruhr-uni-bochum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of allostatic responses of thyroid function after short-term loss of consciousness (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04879147, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.