(Near) Syncope Clinical Trial
Official title:
Syncope Patient Evaluation in the Emergency Department (SPEED)
| Verified date | August 2013 |
| Source | Klinikum Nürnberg |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 397 |
| Est. completion date | May 2012 |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum Nuremberg | Nuremberg | Bavaria |
| Lead Sponsor | Collaborator |
|---|---|
| Klinikum Nürnberg |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | adverse events in patients with syncope and near syncope within 30 days after presentation to the emergency department | 30 days | No | |
| Secondary | prevalence and prognosis of patients with syncope or near syncope in the emergency department | 6 months | No | |
| Secondary | prognostic and diagnostic accuracy of cardiac biomarkers NTproBNP and hs-cTnT | 6 months | No | |
| Secondary | prevalence, prognosis and clinical assessment of elderly patients = 65 years with (near) syncope in the emergency department | 6 months | No |