Validation of the San Francisco Syncope Rule - Full Text View

Sponsored by:	Albert Einstein College of Medicine of Yeshiva University
Information provided by:	Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:	NCT00300625

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

MedlinePlus related topics: Fainting

U.S. FDA Resources

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

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

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:

Quinn JV, Stiell IG, McDermott DA, Kohn MA, Wells GA. The San Francisco Syncope Rule vs physician judgment and decision making. Am J Emerg Med. 2005 Oct;23(6):782-6.

Study ID Numbers:	04-05-109C
Study First Received:	March 7, 2006
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00300625 History of Changes
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

Study placed in the following topic categories:

Signs and Symptoms
Unconsciousness
Consciousness Disorders

Neurologic Manifestations
Neurobehavioral Manifestations
Syncope

Additional relevant MeSH terms:

Signs and Symptoms
Unconsciousness
Nervous System Diseases
Consciousness Disorders

Neurologic Manifestations
Neurobehavioral Manifestations
Syncope

ClinicalTrials.gov processed this record on May 07, 2009