Comparison Between Standard and Ultrasound Integrated Approach for Risk Stratification of Syncope in the Emergency Department

NCT ID: NCT02781207

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 196 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-03-31

Brief 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.

Conditions

Syncope

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Enrico Lupia, MD, PhD

Associate Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU Città della Salute e della Scienza di Torino

Turin, , Italy

Countries

Italy

Other Identifiers

unito_isyncope

Identifier Type: -

Identifier Source: org_study_id