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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01498471
First received: December 20, 2011
Last updated: December 22, 2011
Last verified: December 2011

December 20, 2011
December 22, 2011
January 2012
February 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01498471 on ClinicalTrials.gov Archive Site
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
Same as current
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NICE Guideline 'Red Flags' to Predict Serious Outcome After Transient Loss of Consciousness
NICE Guideline 'Red Flags' to Predict Serious Outcome After Transient Loss of Consciousness: Prospective Validation Study in the Emergency Department.

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Adult patients (>= 16 years) presenting in the ED with a complaint of TLoC

Syncope
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
490
February 2014
February 2013   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact: Peter Vanbrabant, MD 003216343952 peter.vanbrabant@uzleuven.be
Belgium
 
NCT01498471
UZ/PVB/2011
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Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Not Provided
Universitaire Ziekenhuizen Leuven
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP