Syncope Patient Evaluation in the Emergency Department

NCT ID: NCT01916070

Last Updated: 2013-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 397 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-05-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with syncope

No interventions assigned to this group

patients with near syncope

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klinikum Nürnberg

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Michael Christ

Prof. Dr. med. Michael Christ

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Christ, Prof.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Nürnberg

Locations

Klinikum Nuremberg

Nuremberg, Bavaria, Germany

Countries

Germany

Other Identifiers

SPEED01

Identifier Type: -

Identifier Source: org_study_id