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Completed

NCT Number: NCT01916070

Syncope Patient Evaluation in the Emergency Department

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Nuremberg

Nuremberg, Bavaria, 90419, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. adverse events in patients with syncope and near syncope within 30 days after presentation to the emergency department

    Time frame: 30 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Klinikum Nürnberg

Other

Registry information

Official study title

Syncope Patient Evaluation in the Emergency Department (SPEED)

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 5, 2013
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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