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CompletedNCT01916070Updated Aug 5, 2013

Syncope Patient Evaluation in the Emergency Department

An observational study in (Near) Syncope, sponsored by Klinikum Nürnberg. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-05.

Sponsored by Klinikum Nürnberg · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
397
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • (Near) Syncope

Keywords

  • syncope
  • near syncope
  • prognosis
  • emergency department
03

In context

Syncope

226 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's enrollment of 397 is above the median of 221 across 91 observational studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Klinikum Nürnberg is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients presenting with (near) syncope to the emergency department

Inclusion criteria

  • (near) syncope

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
397 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • patients with syncope
  • patients with near syncope
06

What researchers measure

Primary outcomes

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

    Time frame: 30 days

Secondary outcomes

  1. prevalence and prognosis of patients with syncope or near syncope in the emergency department

    Time frame: 6 months

  2. prognostic and diagnostic accuracy of cardiac biomarkers NTproBNP and hs-cTnT

    Time frame: 6 months

  3. prevalence, prognosis and clinical assessment of elderly patients ≥ 65 years with (near) syncope in the emergency department

    Time frame: 6 months

07

Study locations

1 site
  • Klinikum Nuremberg
    Nuremberg, Bavaria 90419, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01916070
Lead sponsor
Klinikum Nürnberg
Responsible party
Prof. Dr. Michael Christ (Prof. Dr. med. Michael Christ, Klinikum Nürnberg) — Principal investigator
First posted
Aug 5, 2013
Start date
Jul 2011
Primary completion
Nov 2011
Completion
May 2012
Last update
Aug 5, 2013

Study contacts

Michael Christ, Prof.
principal investigator · Klinikum Nürnberg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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