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Syncope | Improving Syncope Risk Stratification in Older Adults

Syncope research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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. 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Syncope

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

No treatmentObservational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting)

Study Status

Completed

Start Date: April 2013

Completed Date: December 14, 2016

Phase:

Type: Observational

Design:

Primary Outcome: Combined death and serious cardiac events

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Benjamin C Sun, MD

Lead Sponsor: Oregon Health and Science University

Collaborator: National Institutes of Health (NIH)

More information:https://clinicaltrials.gov/show/NCT01802398

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