ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of the San Francisco Syncope Rule

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00300625
Recruitment Status : Completed
First Posted : March 9, 2006
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Adrienne Birnbaum, Albert Einstein College of Medicine, Inc.

Brief Summary:
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 or disease Intervention/treatment
Syncope Near Syncope Procedure: Application of the San Francisco Syncope Rule

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%.


Study Type : Observational
Time Perspective: Prospective
Official Title: Validation of the San Francisco Syncope Rule
Study Start Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting
U.S. FDA Resources





Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


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): NCT00300625


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

Publications:
Responsible Party: Adrienne Birnbaum, Prof, Dept of Emergency Medicine, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT00300625     History of Changes
Other Study ID Numbers: 04-05-109C
First Posted: March 9, 2006    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by Adrienne Birnbaum, Albert Einstein College of Medicine, Inc.:
Syncope
Near syncope
San Francisco Syncope rule

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