Practical Approaches to Care in Emergency Syncope (PACES)

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Columbia University

Status

Enrolling

Conditions

Syncope
Presyncope

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04533425
GCO 19-0127
R01HL149680 (U.S. NIH Grant/Contract)
AAAT5903

Details and patient eligibility

About

Syncope, or transient loss of consciousness, is a common reason for visit to the Emergency Department and often leads to extensive testing and hospitalization. Using objective risk scores to determine which patients with syncope will actually benefit from these interventions, and which can be safely discharged home with minimal testing, is critical to providing sensible medical care. This study will evaluate the validity of two syncope risk-stratification tools and investigate their impact on healthcare utilization and patient safety, thus improving the quality of care for the 1-2 million patients who experience syncope every year in the United States

Full description

The goal of this project is to improve risk-stratification for patients who present to the emergency department (ED) with syncope (transient loss of consciousness), in order to better delineate which patients require admission and which can be safely discharged home. Syncope and pre-syncope (the sensation of impending loss of consciousness) are common reasons to present to the ED, representing over 1.3 million visits per year in the United States. Although syncope is most often benign, it can occasionally be caused by serious cardiopulmonary diseases such as cardiac arrhythmia, acute coronary syndrome, or pulmonary embolism. Despite thorough evaluation in the ED, the cause of syncope remains unknown in over 50% of cases, which leads to a large number of syncope patients being admitted for observation and/or further testing. These admissions to the hospital or observation unit are low-yield, costly, and expose patients to the possibility of iatrogenic harm. In response to this, two groups of researchers have developed distinct syncope risk-stratification tools: the US Syncope Risk Score (FAINT) and the Canadian Syncope Risk Score. These scores use a combination of clinical, electrocardiographic, and laboratory variables to predict the risk of serious clinical outcomes at 30 days. While promising, these two risk scores require external validation prior to widespread clinical implementation. The study team will prospectively collect data on ~1,270 ED patients with syncope/pre-syncope and follow them for 30 days to validate the predictive accuracy of these two risk scores. The study team will then assess the impact of implementing these scores by measuring their potential effect on healthcare utilization and costs. If validated and shown to safely reduce healthcare utilization, these syncope risk scores could play a major role in improving emergency syncope care by reducing low-yield admissions and identifying patients who are unsafe for discharge from the ED. This study, entitled PACES: Practical Approaches to Care in Emergency Syncope, will help increase the quality and value of emergency care, and advance the field of syncope research.

Enrollment

1,270 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients 40 years of age or older who present to the Emergency Department with syncope or presyncope.
  • Subjects must read and speak English or Spanish.
  • Subjects must have a working phone number and fixed address.

Exclusion criteria

  • Patient who have a syncope mimic such as seizure, stroke, head trauma with loss of consciousness, altered mental status, hypoglycemia, intoxication, or require an intervention to restore consciousness.
  • Patients who have a new serious diagnosis found in the Emergency Department, such as death, significant cardiac arrhythmia (see below), myocardial infarction, significant structural heart disease, stroke (both ischemic and hemorrhagic), pulmonary embolism, aortic dissection, hemorrhage or anemia requiring blood transfusion, subarachnoid hemorrhage, cardiopulmonary resuscitation, acute surgical illness, pregnancy, or major traumatic injury.
  • Significant cardiac arrhythmia includes Ventricular Fibrillation, Ventricular tachycardia (>30 secs), Symptomatic ventricular tachycardia, (<30 secs), Sick sinus disease with alternating sinus bradycardia and tachycardia, Sinus pause > 3 seconds, Mobitz type II atrioventricular heart block, Complete heart block, Symptomatic supraventricular tachycardia (including Paroxysmal Supraventricular Tachycardia (PSVT), rapid atrial fibrillation/ flutter), Symptomatic bradycardia (pulse<40), Pacemaker or implantable cardioverter-defibrillator malfunction with cardiac pauses.

Trial design

1,270 participants in 1 patient group

Patients with syncope
Description:
Patients who present to the ED with syncope

Trial contacts and locations

5

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Central trial contact

Raquel Shrager

Data sourced from clinicaltrials.gov

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