Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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
Syncope

Study Type: Observational
Study Design: 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.

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 490
Study Start Date: January 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498471

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

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

Additional Information:
No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01498471     History of Changes
Other Study ID Numbers: UZ/PVB/2011
Study First Received: December 20, 2011
Last Updated: December 22, 2011
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on November 27, 2014