SyncopeTROPOCOPENCT03528161
Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term
An observational study of Syncope, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Syncope, a frequent reason for emergency room visits and hospitalization, is a symptom of three major etiological entities: cardiac causes, vaso-reflex causes and orthostatic hypotension. The etiological diagnosis is often uncertain and the prognostic assessment orients the outcome of the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Measurement of hypersensitive troponin
- How many people
- 248 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2018to Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Knowing that the number of malaise admitted per year to emergencies is 3972 (2016 data), and 20% are syncope (about 800 syncope per year), recruitment can be done in 12 months. 248 patients admitted for syncope.
Who may be able to join
- Patients admitted to the emergency department for syncope as defined by European Society of Cardiology (ESC) recommendations.
Who cannot join
- Patient under guardianship or safeguard of justice
- Refusal to participate
- Inability to contact the patient again at M1, M3, M6
- Malaise without loss of consciousness (lipothymia)
- Loss of post-traumatic knowledge (after head trauma)
- Loss of consciousness of toxic origin
- Loss of consciousness of confirmed epileptic origin (known epileptic or strongly evocative history with post-critical state)
- Diagnosis performed during the initial emergency assessment of a major adverse cardiovascular event.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
Frédéric Balen, MD, 05 61 32 27 93 ext. 33, balen.f@chu-toulouse.fr
Isabelle Olivier, PhD, 05 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
Syncope, a frequent reason for emergency room visits and hospitalization, is a symptom of three major etiological entities: cardiac causes, vaso-reflex causes and orthostatic hypotension. The etiological diagnosis is often uncertain and the prognostic assessment orients the outcome of the patient. The vast majority of syncope management costs are related to hospitalizations. Hospitalization in the immediate aftermath of emergency care is justified by a short-term prognosis. The current relevance of hospitalizations and the prognostic assessment of syncope is questioned.
Read the detailed description
The improvement of cardiac troponin assay techniques has increased its sensitivity to detect myocardial ischemic conditions, even at the expense of a loss of specificity. Myocardial infarction type 2 is due to an imbalance between needs and oxygen supply to cardiomyocytes at the time of an increase of the first and / or a decrease of the second and is favored by an underlying cardiovascular field fragile. Syncope, because of the low flow that they imply, can be the cause of a type II myocardial infarction on fragile cardiovascular ground.
The study is prospectively conducted in all patients admitted for syncope to assess the actual diagnostic performance of hypersensitive troponin in the syncope risk stratification. The primary benefit is to identify patients at risk of serious cardiac events in the short term. The secondary benefits expected from the study are a decrease in unjustified hospitalizations of patients admitted to the emergency for syncope and thus a decrease in the cost of care.
The validation of the indication of the troponin assay in the stratification of the risk after a syncope passes by its prospective evaluation in a prognostic study.
- Conditions
- Syncope
- Being tested
- Measurement of hypersensitive troponin
- Keywords
- hypersensitive troponin, risk of serious adverse events, emergency
- Medical subject headings
- Syncope, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of hypersensitive troponinOther
Telephone follow-up at one month, 3 months and 6 months by a clinical research technician. Collection of serious adverse events, reports of hospitalization.
The hypersensitive troponin assay will be recently proposed in a short-term risk stratification score after syncope (30 days), the canadian syncope risk score. If hypersensitive troponin benefits from interesting performances it needs to be evaluated prospectively, as measured only in 47.9% of syncope in this study. Hypersensitive troponin could be a prognostic marker of early serious adverse cardiovascular events in syncope.
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event
The sensitivity of hypersensitive troponin in predicting the occurrence within 30 days of a major undesirable cardiovascular adverse event Positive and negative likelihood ratios (defined from sensitivity and specificity) will also be estimated.
The definition of a major cardiovascular adverse event was chosen based on recommendations published in the Academy of Emergency Medicine (38) and the American College of Emergency Medicine The primary endpoint will be evaluated in all patients within 30 days of the troponin assay, blinded to the outcome of the biological variable.
Measured: 30 days
The specificity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event
The specificity of hypersensitive troponin in predicting the occurrence within 30 days of a major undesirable cardiovascular adverse event Positive and negative likelihood ratios (defined from sensitivity and specificity) will also be estimated.
The definition of a major cardiovascular adverse event was chosen based on recommendations published in the Academy of Emergency Medicine (38) and the American College of Emergency Medicine The primary endpoint will be evaluated in all patients within 30 days of the troponin assay, blinded to the outcome of the biological variable.
Measured: 30 days
Secondary outcomes (2)
The positive and negative predictive values of hypersensitive troponin
The positive and negative predictive values of hypersensitive troponin in the prediction of short-term serious events
Measured: 6 months
The hypersensitive troponin performance
The hypersensitive troponin performance (sensitivity) in the prediction of the occurrence of a major adverse cardiovascular event at 3 and 6 months after syncope
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start19 Jun 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Balen, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528161
- Sponsor's protocol ID
- RC31/18/0118
- Other IDs
- 2018-A01278-47
- Acronym
- TROPOCOPE
- Status last verified
- Jul 2018
- First submitted
- 3 May 2018
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypersensitive Troponin Performance to Identify Syncope at Risk of Serious Adverse Events in the Short Term
- ClinicalTrials.gov ID
- NCT03528161
- Acronym / sponsor ID
- TROPOCOPE / RC31/18/0118
- Conditions
- Syncope
- Keywords
- hypersensitive troponin, risk of serious adverse events, emergency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 May 2018 (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.
Syncope, a frequent reason for emergency room visits and hospitalization, is a symptom of three major etiological entities: cardiac causes, vaso-reflex causes and orthostatic hypotension. The etiological diagnosis is often uncertain and the prognostic assessment orients the outcome of the patient. The vast majority of syncope management costs are related to hospitalizations. Hospitalization in the immediate aftermath of emergency care is justified by a short-term prognosis. The current relevance of hospitalizations and the prognostic assessment of syncope is questioned.
Detailed description
The improvement of cardiac troponin assay techniques has increased its sensitivity to detect myocardial ischemic conditions, even at the expense of a loss of specificity. Myocardial infarction type 2 is due to an imbalance between needs and oxygen supply to cardiomyocytes at the time of an increase of the first and / or a decrease of the second and is favored by an underlying cardiovascular field fragile. Syncope, because of the low flow that they imply, can be the cause of a type II myocardial infarction on fragile cardiovascular ground.
The study is prospectively conducted in all patients admitted for syncope to assess the actual diagnostic performance of hypersensitive troponin in the syncope risk stratification. The primary benefit is to identify patients at risk of serious cardiac events in the short term. The secondary benefits expected from the study are a decrease in unjustified hospitalizations of patients admitted to the emergency for syncope and thus a decrease in the cost of care.
The validation of the indication of the troponin assay in the stratification of the risk after a syncope passes by its prospective evaluation in a prognostic study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Knowing that the number of malaise admitted per year to emergencies is 3972 (2016 data), and 20% are syncope (about 800 syncope per year), recruitment can be done in 12 months. 248 patients admitted for syncope.
Key inclusion criteria (1 listed)
- Patients admitted to the emergency department for syncope as defined by European Society of Cardiology (ESC) recommendations.
Key exclusion criteria (8 listed)
- Patient under guardianship or safeguard of justice
- Refusal to participate
- Inability to contact the patient again at M1, M3, M6
- Malaise without loss of consciousness (lipothymia)
- Loss of post-traumatic knowledge (after head trauma)
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 |
|---|---|---|
| Measurement of hypersensitive troponinTelephone follow-up at one month, 3 months and 6 months by a clinical research technician. Collection of serious adverse events, reports of hospitalization. The hypersensitive troponin assay will be recently proposed in a short-term risk stratification score after syncope (30 days), the canadian syncope risk score. If hypersensitive troponin benefits from interesting performances it needs to be evaluated prospectively, as measured only in 47.9% of syncope in this study. Hypersensitive troponin could be a prognostic marker of early serious adverse cardiovascular events in syncope. | Other | – |
Primary outcome
The sensitivity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event
Time frame: 30 days
The sensitivity of hypersensitive troponin in predicting the occurrence within 30 days of a major undesirable cardiovascular adverse event Positive and negative likelihood ratios (defined from sensitivity and specificity) will also be estimated. The definition of a major cardiovascular adverse event was chosen based on recommendations published in the Academy of Emergency Medicine (38) and the American College of Emergency Medicine The primary endpoint will be evaluated in all patients within 30 days of the troponin assay, blinded to the outcome of the biological variable.
The specificity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event
Time frame: 30 days
The specificity of hypersensitive troponin in predicting the occurrence within 30 days of a major undesirable cardiovascular adverse event Positive and negative likelihood ratios (defined from sensitivity and specificity) will also be estimated. The definition of a major cardiovascular adverse event was chosen based on recommendations published in the Academy of Emergency Medicine (38) and the American College of Emergency Medicine The primary endpoint will be evaluated in all patients within 30 days of the troponin assay, blinded to the outcome of the biological variable.
2 secondary outcomes
The positive and negative predictive values of hypersensitive troponin
Time frame: 6 months
The hypersensitive troponin performance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Syncope
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Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
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Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
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Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
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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.
Frédéric Balen, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope, run by University Hospital, Toulouse at 1 site in France.
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 1 inclusion and 8 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 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Frédéric Balen, MD (05 61 32 27 93 ext. 33, balen.f@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of hypersensitive troponin in predicting a major undesirable cardiovascular adverse event (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2018.