Validation of the San Francisco Syncope Rule

This study has been completed.
Sponsor:
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00300625
First received: March 7, 2006
Last updated: February 17, 2009
Last verified: March 2006
  Purpose

This study was designed to validate the "San Francisco Syncope Rule". This set of rules was derived by Quinn et. al. to help guide the treatment of patients evaluated in the Emergency Department who had an episode of syncope (passed out) or near syncope (almost passed out). A rule that considers patients with an abnormal ECG, a complaint of shortness of breath, hematocrit less than 30%, systolic blood pressure less than 90 mm Hg, or a history of congestive heart failure was shown predict with a good degree of accuracy which patients would have an adverse event and require admission.


Condition Intervention
Syncope
Near Syncope
Procedure: Application of the San Francisco Syncope Rule

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation of the San Francisco Syncope Rule

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Study Start Date: January 2005
Detailed Description:

This study was designed to validate the "San Francisco Syncope Rule". This set of rules was derived by Quinn et. al. to help guide the treatment of patients evaluated in the Emergency Department who had an episode of syncope or near syncope.

A rule that considers patients with an abnormal ECG, a complaint of shortness of breath, hematocrit less than 30%, systolic blood pressure less than 90 mm Hg, or a history of congestive heart failure was shown predict with a good degree of accuracy which patients would have an adverse event/serious outcome and require admission. Serious outcomes include the following: death,myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant hemorrhage, or any condition causing a return ED visit and hospitalization for a related event.

In Quinn's derivation trial, the sensitivity of the rule was 96%.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Acute syncope or near syncope as a reason for the ED visit

Exclusion Criteria: Altered mental status, alcohol or illicit drug-related loss of consciousness, Definite seizure, Transient loss of consciousness caused by head trauma

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00300625

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Adrienne J Birnbaum, MD Albert Einstein College of Medicine of Yeshiva University
Study Chair: E J Gallagher, MD Montefiore Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00300625     History of Changes
Other Study ID Numbers: 04-05-109C
Study First Received: March 7, 2006
Last Updated: February 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Syncope
Near syncope
San Francisco Syncope rule

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

ClinicalTrials.gov processed this record on October 30, 2014