Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02781207
Other study ID # unito_isyncope
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date March 2018

Study information

Verified date November 2022
Source University of Turin, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date March 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients evaluated in the Emergency Department for loss of consciousness Exclusion Criteria: - identification of cause of loss of consciousness after initial evaluation; - loss of consciousness classified as high risk syncope.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy AOU Città della Salute e della Scienza di Torino Turin

Sponsors (1)

Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of low risk acute syncope reclassified to intermediate/high risk after integrated point-of-care ultrasound evaluation 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)
Primary number of intermediate risk acute syncope reclassified to low risk after integrated point-of-care ultrasound evaluation 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)
Primary number of intermediate risk acute syncope reclassified to high risk after integrated point-of-care ultrasound evaluation 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)
See also
  Status Clinical Trial Phase
Completed NCT06038708 - Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial
Completed NCT00069693 - Evaluation of Chronic Orthostatic Intolerance N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Completed NCT02565238 - BIO.MASTER.BioMonitor 2 Study N/A
Active, not recruiting NCT01965899 - Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System N/A
Completed NCT00746564 - Study of New Implantable Loop Recorder N/A
Completed NCT00359203 - ISSUE3: International Study on Syncope of Uncertain Etiology 3 Phase 4
Recruiting NCT04972071 - SW-RCT Implementation of Canadian Syncope Risk Score Based Practice Recommendations N/A
Completed NCT04198220 - BIO|STREAM.ICM Obesity
Recruiting NCT04533425 - Practical Approaches to Care in Emergency Syncope
Completed NCT05571254 - The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments
Recruiting NCT05621460 - The Effect of Water Carbonation on Orthostatic Tolerance N/A
Not yet recruiting NCT05957315 - Mobile Cardiac Outpatient Telemetry for Unexplained Syncope N/A
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Completed NCT05729724 - Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)
Completed NCT05782712 - Rapid Measurement of Adenosine in Syncope Patients
Completed NCT03786640 - Abbott Brady 3T MRI PMCF
Recruiting NCT03803969 - ConfirmRxTM: Posture and Activity N/A
Recruiting NCT05575934 - Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department
Recruiting NCT04075084 - Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)