Validation of the San Francisco Syncope Rule

NCT ID: NCT00300625

Last Updated: 2018-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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%.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Syncope Near Syncope

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Application of the San Francisco Syncope Rule

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adrienne Birnbaum

Prof, Dept of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Adrienne J Birnbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

E J Gallagher, MD

Role: STUDY_CHAIR

Montefiore Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1016/j.ajem.2004.11.009.

Reference Type BACKGROUND
PMID: 16182988 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

04-05-109C

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mechanisms of Vasovagal Syncope
NCT01791816 COMPLETED EARLY_PHASE1
CSRS Implementation - A Pilot Study
NCT04790058 ACTIVE_NOT_RECRUITING