SyncopeNCT02781207
Comparison Between Standard and Ultrasound Integrated Approach for Risk Stratification of Syncope in the Emergency Department
An observational study of Syncope, run by University of Turin, Italy at 1 site in Italy.
Trial summary
This is a observational prospective study. For patients presenting to the Emergency Department with loss of consciousness, emergency physicians will be asked to screen the real syncope without an evident and immediate cause for the loss of consciousness (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- How many people
- 196 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2016to Mar 2018
- 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: The study cohort is composed of all adult patients evaluate in the Emergency Department for syncope (defined as transient loss of consciousness due to global cerebral hypoperfusion characterized by rapid onset, short duration, and spontaneous complete recovery, and unrelated to trauma). After first evaluation, high risk syncope will be excluded.
Who may be able to join
- patients evaluated in the Emergency Department for loss of consciousness
Who cannot join
- identification of cause of loss of consciousness after initial evaluation;
- loss of consciousness classified as high risk syncope.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Standard and Bedside Ultrasound Integrated Approach for Risk Stratification of Patients Presenting With Syncope in the Emergency Department
This is a observational prospective study. For patients presenting to the Emergency Department with loss of consciousness, emergency physicians will be asked to screen the real syncope without an evident and immediate cause for the loss of consciousness (e.g. vasovagal) and/or at least one high risk condition as listed by the European Society of Cardiology in the 2009 Guidelines for the diagnosis and management of syncope (i.e. severe structural or coronary artery disease, clinical or ECG features suggesting arrhythmic syncope, and important co-morbidities).
In case of a real syncope not clearly physiopathologically explained and no high risk conditions, the emergency physician in charge will check risk factors for high risk syncope and categorize again every cases.
Read more
A high risk syncope is characterized by at least one high-risk characteristic (based on 2015 "Syncope clinical management in the emergency department consensus"): syncope during exertion, in supine position, with new onset of chest discomfort, palpitations before the loss of consciousness, family history of sudden death, congestive heart failure, aortic stenosis, left ventricular outflow tract disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, left ventricular ejection fraction <35%, previously documented ventricular arrhythmia, coronary artery disease, congenital heart disease, previous myocardial infarction, pulmonary hypertension, previous ICD implantation, anemia (i.e. Hb <9 g/dl), lowest systolic blood pressure in the ED <90 mmHg, sinus bradycardia (<40 bpm), new (or previously unknown) left bundle branch block, bifascicular block plus a first degree AV block, Brugada ECG pattern, ECG changes consistent with acute ischemia, a new non-sinus rhythm, bifascicular block, and a prolonged QTc (>450 ms).
Low and intermediate risk syncopes will be enrolled and evaluated using an integrated point-of-care sonographic approach (based on history, physical exam, electrocardiogram, and lung, focus cardiac and venous compression ultrasonography).
After discharge, the risk of patient's syncope will be determined by reviewing the entire medical records.
- Conditions
- Syncope
- Keywords
- syncope, point-of-care ultrasound
- Medical subject headings
- Syncope
What is being measured
The primary outcome is the main question the study is designed to answer.
number of low risk acute syncope reclassified to intermediate/high risk after integrated point-of-care ultrasound evaluation
Measured: during the stay in the Emergency Department (ideally within 6 hours or, if patient will be admitted in the observational unit ward, within 36 hours)
number of intermediate risk acute syncope reclassified to low risk after integrated point-of-care ultrasound evaluation
Measured: during the stay in the Emergency Department (ideally within 6 hours or, if patient will be admitted in the observational unit ward, within 36 hours)
number of intermediate risk acute syncope reclassified to high risk after integrated point-of-care ultrasound evaluation
Measured: during the stay in the Emergency Department (ideally within 6 hours or, if patient will be admitted in the observational unit ward, within 36 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2018
- Study completionMar 2018
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Lupia, MD, PhD, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781207
- Sponsor's protocol ID
- unito_isyncope
- Status last verified
- Nov 2022
- First submitted
- 11 May 2016
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The study collect only clinical data, also reported in the Emergency Department chart. The chart is always given to the patient at the discharge.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Standard and Bedside Ultrasound Integrated Approach for Risk Stratification of Patients Presenting With Syncope in the Emergency Department
- ClinicalTrials.gov ID
- NCT02781207
- Acronym / sponsor ID
- unito_isyncope
- Conditions
- Syncope
- Keywords
- syncope, point-of-care ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 24 May 2016 (estimated)
- 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.
This is a observational prospective study. For patients presenting to the Emergency Department with loss of consciousness, emergency physicians will be asked to screen the real syncope without an evident and immediate cause for the loss of consciousness (e.g. vasovagal) and/or at least one high risk condition as listed by the European Society of Cardiology in the 2009 Guidelines for the diagnosis and management of syncope (i.e. severe structural or coronary artery disease, clinical or ECG features suggesting arrhythmic syncope, and important co-morbidities).
In case of a real syncope not clearly physiopathologically explained and no high risk conditions, the emergency physician in charge will check risk factors for high risk syncope and categorize again every cases.
A high risk syncope is characterized by at least one high-risk characteristic (based on 2015 "Syncope clinical management in the emergency department consensus"): syncope during exertion, in supine position, with new onset of chest discomfort, palpitations before the loss of consciousness, family history of sudden death, congestive heart failure, aortic stenosis, left ventricular outflow tract disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, left ventricular ejection fraction <35%, previously documented ventricular arrhythmia, coronary artery disease, congenital heart disease, previous myocardial infarction, pulmonary hypertension, previous ICD implantation, anemia (i.e. Hb <9 g/dl), lowest systolic blood pressure in the ED <90 mmHg, sinus bradycardia (<40 bpm), new (or previously unknown) left bundle branch block, bifascicular block plus a first degree AV block, Brugada ECG pattern, ECG changes consistent with acute ischemia, a new non-sinus rhythm, bifascicular block, and a prolonged QTc (>450 ms).
Low and intermediate risk syncopes will be enrolled and evaluated using an integrated point-of-care sonographic approach (based on history, physical exam, electrocardiogram, and lung, focus cardiac and venous compression ultrasonography).
After discharge, the risk of patient's syncope will be determined by reviewing the entire medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort is composed of all adult patients evaluate in the Emergency Department for syncope (defined as transient loss of consciousness due to global cerebral hypoperfusion characterized by rapid onset, short duration, and spontaneous complete recovery, and unrelated to trauma). After first evaluation, high risk syncope will be excluded.
Key inclusion criteria (1 listed)
- patients evaluated in the Emergency Department for loss of consciousness
Key exclusion criteria (2 listed)
- identification of cause of loss of consciousness after initial evaluation;
- loss of consciousness classified as high risk syncope.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of low risk acute syncope reclassified to intermediate/high risk after integrated point-of-care ultrasound evaluation
Time frame: during the stay in the Emergency Department (ideally within 6 hours or, if patient will be admitted in the observational unit ward, within 36 hours)
number of intermediate risk acute syncope reclassified to low risk after integrated point-of-care ultrasound evaluation
Time frame: during the stay in the Emergency Department (ideally within 6 hours or, if patient will be admitted in the observational unit ward, within 36 hours)
number of intermediate risk acute syncope reclassified to high risk after integrated point-of-care ultrasound evaluation
Time frame: during the stay in the Emergency Department (ideally within 6 hours or, if patient will be admitted in the observational unit ward, within 36 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Yes. The study collect only clinical data, also reported in the Emergency Department chart. The chart is always given to the patient at the discharge.
Related trials for Syncope
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
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.
The record lists no contact. Use the official record to reach the sponsor.
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 of Turin, Italy at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 3 Nov 2022. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of low risk acute syncope reclassified to intermediate/high risk after integrated point-of-care ultrasound evaluation (time frame: during the stay in the Emergency Department (ideally within 6 hours or, if patient will be admitted in the observational unit ward, within 36 hours)). The study lists 3 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 3 Nov 2022.