Trial record 2 of 198 for:    Syncope

Syncope Patient Evaluation in the Emergency Department

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Michael Christ, Klinikum Nürnberg
ClinicalTrials.gov Identifier:
NCT01916070
First received: August 2, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

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
(Near) Syncope

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Syncope Patient Evaluation in the Emergency Department (SPEED)

Resource links provided by NLM:


Further study details as provided by Klinikum Nürnberg:

Primary Outcome Measures:
  • adverse events in patients with syncope and near syncope within 30 days after presentation to the emergency department [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • prevalence and prognosis of patients with syncope or near syncope in the emergency department [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • prognostic and diagnostic accuracy of cardiac biomarkers NTproBNP and hs-cTnT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • prevalence, prognosis and clinical assessment of elderly patients ≥ 65 years with (near) syncope in the emergency department [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 397
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with syncope
patients with near syncope

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients presenting with (near) syncope to the emergency department

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01916070

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

No publications provided

Responsible Party: Prof. Dr. Michael Christ, Prof. Dr. med. Michael Christ, Klinikum Nürnberg
ClinicalTrials.gov Identifier: NCT01916070     History of Changes
Other Study ID Numbers: SPEED01
Study First Received: August 2, 2013
Last Updated: August 2, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum Nürnberg:
syncope
near syncope
prognosis
emergency department

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

ClinicalTrials.gov processed this record on September 18, 2014