Syncope Patient Evaluation in the Emergency Department

NCT01916070 | Completed

• 1 other identifier: SPEED01
• Study Type: observational
• Target: 397
• Locations: 1 country
• Sites: 1

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.

Conditions

(Near) Syncope

Keywords

syncope; near syncope; prognosis; emergency department

Outcome Measures

Primary Outcomes (1)

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

  30 days

Secondary Outcomes (3)

• 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

Study Arms (2)

patients with syncope

patients with near syncope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients presenting with (near) syncope to the emergency department

You may qualify if:

• (near) syncope

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Nürnberg: lead

Study Sites (1)

Klinikum Nuremberg

Nuremberg, Bavaria, 90419, Germany

Location

MeSH Terms

Conditions

Syncope; Emergencies

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Michael Christ, Prof.

  Klinikum Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Michael Christ

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 5, 2013
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: May 1, 2012
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

DE (1)