Syncope Patient Evaluation in the Emergency Department

Completed

• Conditions: (Near) Syncope

• Registration Number: NCT01916070
• Lead Sponsor: Klinikum Nürnberg

Brief Summary

Patients with the symptom complex syncope or near-syncope are quite often in the emergency department. Most patients with syncope have a positive prognosis. However some types of syncope are associated with an increased morbidity and mortality. It is a challenge to detect these patients reliably at an early stage. The current guidelines contain exact definitions concerning the characteristics of patients with syncope and recommendations on how to diagnose and treat these patients following standardized pathways. Due to the fact that near-syncope is poorly defined and therefore seldom evaluated in clinical trials, data concerning near-syncope are rare.

Our aim was to characterize patients presenting with syncope or near-syncope to the emergency department regarding their risk profile, comorbidities and prognosis. First we evaluated if there is a difference between the two groups syncope and near-syncope concerning type and frequency of adverse events. Furthermore we analyzed the routinely measured cardiac biomarkers NT-proBNP and hs cTnT in patients with syncope or near-syncope. Then we determined both their prognostic accuracy in predicting adverse events and their diagnostic accuracy in finding the underlying etiology. Finally we analyzed a special patient collective, patients aged ≥ 65 years. It is assumed that elderly patients are suffering from comorbidities and age-related physiological and cognitive disabilities. We therefore hypothesize that elderly patients, in contrast to patients aged \< 60, display an increased risk of adverse events and that they have a poorer prognosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-11
• Study Completion: 2012-05
• Status Verified: 2013-08
• Study First Submitted: 2013-08-02
• Study First Submitted QC: 2013-08-02
• Last Update Submitted: 2013-08-02
• Study First Posted: 2013-08-05
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

Inclusion Criteria

• (near) syncope

Exclusion Criteria

• age < 18 years
• progressive impairment of consciousness
• use of mind-altering drugs
• non syncopal loss of consciousness: hyperventilation, hypoglycaemia, metabolic disorders, psychogenic pseudosyncope, TIA or stroke, seizure, transient loss of consciousness caused by craniocerebral injury

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adverse events in patients with syncope and near syncope within 30 days after presentation to the emergency department	30 days

Secondary Outcome Measures

Name	Time	Method
prevalence and prognosis of patients with syncope or near syncope in the emergency department	6 months
prognostic and diagnostic accuracy of cardiac biomarkers NTproBNP and hs-cTnT	6 months
prevalence, prognosis and clinical assessment of elderly patients ≥ 65 years with (near) syncope in the emergency department	6 months

Trial Locations

Locations (1)

Klinikum Nuremberg; 🇩🇪 Nuremberg, Bavaria, Germany