Syncope Patient Evaluation in the Emergency Department

Syncope Patient Evaluation in the Emergency Department (SPEED)

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.

Study Overview

• Status: Completed
• Conditions: (Near) Syncope

• Study Type: Observational
• Enrollment (Actual): 397

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Nuremberg, Bavaria, Germany, 90419
      • Klinikum Nuremberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients presenting with (near) syncope to the emergency department

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patients with syncope
patients with near syncope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
adverse events in patients with syncope and near syncope within 30 days after presentation to the emergency department	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Klinikum Nürnberg
• Investigators: Principal Investigator: Michael Christ, Prof., Klinikum Nürnberg

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: August 2, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Estimate): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 2, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: prognosis; syncope; emergency department; near syncope
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Unconsciousness; Consciousness Disorders; Emergencies; Syncope
• Other Study ID Numbers: SPEED01