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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 7, 2006 | ||||||||
| Last Updated Date | February 17, 2009 | ||||||||
| Start Date ICMJE | January 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00300625 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Validation of the San Francisco Syncope Rule | ||||||||
| Official Title ICMJE | Validation of the San Francisco Syncope Rule | ||||||||
| 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. |
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| 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%. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: Application of the San Francisco Syncope Rule | ||||||||
| Study Arms / Comparison Groups | |||||||||
| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||||||
| Ages | 21 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00300625 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 04-05-109C | ||||||||
| Study Sponsor ICMJE | Albert Einstein College of Medicine of Yeshiva University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Albert Einstein College of Medicine of Yeshiva University | ||||||||
| Verification Date | March 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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