Clinical Trials Directory

Trials / Completed

CompletedNCT01916070

Syncope Patient Evaluation in the Emergency Department

Syncope Patient Evaluation in the Emergency Department (SPEED)

Status
Completed
Phase
Study type
Observational
Enrollment
397 (actual)
Sponsor
Klinikum Nürnberg · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2011-07-01
Primary completion
2011-11-01
Completion
2012-05-01
First posted
2013-08-05
Last updated
2013-08-05

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01916070. Inclusion in this directory is not an endorsement.