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| Sponsored by: |
Montefiore Medical Center |
|---|---|
| Information provided by: | Montefiore Medical Center |
| 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 |
| Study Type: | Observational |
| Study Design: | Longitudinal, Defined Population, Prospective Study |
| Official Title: | Validation of the San Francisco Syncope Rule |
| Study Start Date: | January 2005 |
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 |
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| Contact: Adrienne J Birnbaum, MD | 718-918-5814 | |
| Contact: David Esses, MD | 718-920-2084 | desses@montefiore.org |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: David Esses, MD 718-920-2084 desses@montefiore.org | |
| Sub-Investigator: David Esses, MD | |
| Sub-Investigator: Polly E Bijur, PhD | |
| Sub-Investigator: Andrew Wollowitz, MD | |
| 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
| Study ID Numbers: | 04-05-109C |
| Study First Received: | March 7, 2006 |
| Last Updated: | March 7, 2006 |
| ClinicalTrials.gov Identifier: | NCT00300625 |
| Health Authority: | United States: Institutional Review Board |
|
Syncope Near syncope San Francisco Syncope rule |
|
Signs and Symptoms Unconsciousness Consciousness Disorders |
Neurologic Manifestations Neurobehavioral Manifestations Syncope |
|
Nervous System Diseases |
