Syncope Patient Evaluation in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01916070
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : August 5, 2013
Information provided by (Responsible Party):
Prof. Dr. Michael Christ, Klinikum Nürnberg

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.

Condition or disease
(Near) Syncope

Study Type : Observational [Patient Registry]
Actual Enrollment : 397 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Syncope Patient Evaluation in the Emergency Department (SPEED)
Study Start Date : July 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

patients with syncope
patients with near syncope

Primary Outcome Measures :
  1. adverse events in patients with syncope and near syncope within 30 days after presentation to the emergency department [ Time Frame: 30 days ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01916070

Klinikum Nuremberg
Nuremberg, Bavaria, Germany, 90419
Sponsors and Collaborators
Klinikum Nürnberg
Principal Investigator: Michael Christ, Prof. Klinikum Nürnberg

Responsible Party: Prof. Dr. Michael Christ, Prof. Dr. med. Michael Christ, Klinikum Nürnberg Identifier: NCT01916070     History of Changes
Other Study ID Numbers: SPEED01
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013

Keywords provided by Prof. Dr. Michael Christ, Klinikum Nürnberg:
near syncope
emergency department

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms