AOU Città della Salute e della Scienza di Torino
Turin, 10126, Italy
NCT Number: NCT02781207
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.
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Notify Me18 year and older
All sexes
Observational
Turin, 10126, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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)
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)
University of Turin, Italy
Other
Comparison Between Standard and Bedside Ultrasound Integrated Approach for Risk Stratification of Patients Presenting With Syncope in the Emergency Department
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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