Clinical trial NCT01916070: Syncope Patient Evaluation in the Emergency Department
Official title: Syncope Patient Evaluation in the Emergency Department (SPEED)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: (Near) Syncope
Keywords: syncope
near syncope
prognosis
emergency department
Lead sponsor: Klinikum Nürnberg
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients presenting with (near) syncope to the emergency department

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.


Eligibility criteria: 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

Primary outcomes:
measure: adverse events in patients with syncope and near syncope within 30 days after presentation to the emergency department
timeFrame: 30 days
Secondary outcomes:
measure: prevalence and prognosis of patients with syncope or near syncope in the emergency department
timeFrame: 6 months
measure: prognostic and diagnostic accuracy of cardiac biomarkers NTproBNP and hs-cTnT
timeFrame: 6 months
measure: prevalence, prognosis and clinical assessment of elderly patients ≥ 65 years with (near) syncope in the emergency department
timeFrame: 6 months
Other outcomes:
Locations:
city: Nuremberg
country: Germany
facility: Klinikum Nuremberg
state: Bavaria
Study officials:
affiliation: Klinikum Nürnberg
name: Michael Christ, Prof.
role: PRINCIPAL_INVESTIGATOR
References: