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NICE Guideline 'Red Flags' to Predict Serious Outcome After Transient Loss of Consciousness

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ClinicalTrials.gov Identifier: NCT01498471
Recruitment Status : Unknown
Verified December 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
First Posted : December 23, 2011
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
This study is designed to evaluate the accuracy of the National Institute for Health and Clinical Excellence (NICE) guideline 'red flags' to identify patients at high risk of short term serious outcome when presenting in the emergency department (ED) with Transient Loss of Consciousness (TLoC). Red flags were defined as ECG abnormality, history or physical signs of heart failure, TLoC during exercise, family history of sudden cardiac death at an age < 40 years and/or an inherited cardiac condition, new or unexplained breathlessness, heart murmur, absence of prodromal symptoms in any patient aged > 65 years.

Condition or disease
Syncope

Study Type : Observational
Estimated Enrollment : 490 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NICE Guideline 'Red Flags' to Predict Serious Outcome After Transient Loss of Consciousness: Prospective Validation Study in the Emergency Department.
Study Start Date : January 2012
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting
U.S. FDA Resources




Primary Outcome Measures :
  1. serious outcome [ Time Frame: day 7 ]
    death, myocardial infarction, arrhythmias, pulmonary embolism, stroke or transient ischemic attack, subarachnoid or non traumatic cerebral haemorrhage, aortic dissection, new diagnosis of structural heart disease thought to be related to syncope, and significant haemorraghe or anemia requiring blood transfusion, readmission for similar symptoms related to the initial event and acute intervention during hospital admission


Secondary Outcome Measures :
  1. serious outcome [ Time Frame: 1 year ]
    death, myocardial infarction, arrhythmias, pulmonary embolism, stroke or transient ischemic attack, subarachnoid or non traumatic cerebral haemorrhage, aortic dissection, new diagnosis of structural heart disease thought to be related to syncope, and significant haemorraghe or anemia requiring blood transfusion, readmission for similar symptoms related to the initial event and acute intervention during hospital admission



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients (>= 16 years) presenting in the ED with a complaint of TLoC
Criteria

Inclusion Criteria:

  • Adult patients (>= 16 years) with a complaint of TLoC

Exclusion Criteria:

  • Patients needing immediate treatment, with trauma related or drug or alcohol related TLoC were excluded, as well as patient with persistent altered level of consciousness, simple fall and drop attack

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 ClinicalTrials.gov identifier (NCT number): NCT01498471


Contacts
Contact: Peter Vanbrabant, MD 003216343952 peter.vanbrabant@uzleuven.be

Locations
Belgium
University Hospitals Leuven
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

Additional Information:
Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01498471     History of Changes
Other Study ID Numbers: UZ/PVB/2011
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms