Improving Syncope Risk Stratification in Older Adults

Completed

• Conditions: Syncope

• Registration Number: NCT01802398
• Lead Sponsor: University of Pennsylvania

Brief Summary

Syncope (temporary loss of consciousness) is a frequent reason for an emergency department (ED) visit among older adults. The current ED evaluation of syncope frequently leads to hospitalization, results in low diagnostic yield, and is enormously costly. The purpose of this protocol is to improve risk prediction for syncope. Improved risk prediction will inform the design of interventions to safely reduce unnecessary health service use.

This is a multi-center, prospective, observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting). The primary outcome is a composite of 30-day cardiac death and serious cardiac events.

Study Aims and Hypotheses are:

Specific Aim 1. Describe serious outcomes after unexplained syncope; rates and reasons for admission; and frequency, diagnostic yield, and therapeutic impact of inpatient diagnostic tests.

H1: Current patterns of care representing a diversity of practice settings and patient populations are costly with low clinical benefit.

Specific Aim 2. Derive and validate a novel risk prediction model for 30-day cardiac death and serious cardiac outcomes after unexplained syncope.

H2: Explicit criteria including contemporary cardiac biomarkers will improve risk stratification compared to unstructured physician assessment and published risk models.

Specific Aim 3. Assess safety and costs of a risk-tailored diagnostic algorithm compared to existing care for unexplained syncope.

H3: A risk-tailored diagnostic algorithm can safely reduce the costs of evaluating unexplained syncope in older adults.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-03-01
• Study Start: 2013-04
• Primary Completion: 2016-09-21
• Study Completion: 2016-12-14
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3707

Inclusion Criteria

1. age≥60 years; AND
2. a complaint of syncope or near-syncope. Syncope is defined as a transient loss of consciousness (LOC), associated with loss of postural tone, with immediate, spontaneous, and complete recovery. Near-syncope is the sensation of imminent syncope without loss of consciousness.

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Exclusion Criteria

• Seizure as presumptive cause of LOC
• Stroke or transient ischemic attack as presumptive cause of LOC
• LOC AFTER head trauma Confusion from baseline mental status
• Intoxicated (alcohol or other drugs)
• Medical or electrical intervention to restore consciousness
• Hypoglycemia as presumptive cause of LOC
• inability to provide follow-up information, including patients who do not speak English (or Spanish, if applicable for study site), lack phone access, or lack a permanent address
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined death and serious cardiac events	30 days	This aim tests the hypothesis that current patterns of care are costly with low clinical benefit. We will generate tables that describe the demographics, clinical characteristics, and disposition of the study cohort, stratified by occurrence of the primary outcome. Outcomes experienced by the study cohort will be described in detail.

Trial Locations

Locations (10)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beaumont Health System; 🇺🇸 Royal Oak, Michigan, United States

Summa Health System, Department of Emergency Medicine (Research); 🇺🇸 Akron, Ohio, United States

URMC, Emergency Department; 🇺🇸 Rochester, New York, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of California, Davis | UC Davis; 🇺🇸 Sacramento, California, United States

Wakeforest, Department of Emergency Medicine; 🇺🇸 Winston-Salem, North Carolina, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States