Clinical trial NCT04533425: Practical Approaches to Care in Emergency Syncope
Official title: Practical Approaches to Care in Emergency Syncope
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Presyncope
Keywords: Risk Score
Risk Stratification
External Validation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-08-31
Enrollment: 1297
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who presents to the Emergency Department (ED) after an episode of syncope or pre-syncope and who do not have a new serious diagnosis found during the index ED evaluation. There are no exclusions based on sex/gender, race, or ethnicity.

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: US Syncope Risk Score (The FAINT Score)
timeFrame: 30 days
measure: Canadian Syncope Risk Score
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Columbia University
name: Marc A Probst, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Probst MA, Kanzaria HK, Gbedemah M, Richardson LD, Sun BC. National trends in resource utilization associated with ED visits for syncope. Am J Emerg Med. 2015 Aug;33(8):998-1001. doi: 10.1016/j.ajem.2015.04.030. Epub 2015 Apr 24.
citation: Probst MA, Gibson T, Weiss RE, Yagapen AN, Malveau SE, Adler DH, Bastani A, Baugh CW, Caterino JM, Clark CL, Diercks DB, Hollander JE, Nicks BA, Nishijima DK, Shah MN, Stiffler KA, Storrow AB, Wilber ST, Sun BC. Risk Stratification of Older Adults Who Present to the Emergency Department With Syncope: The FAINT Score. Ann Emerg Med. 2020 Feb;75(2):147-158. doi: 10.1016/j.annemergmed.2019.08.429. Epub 2019 Oct 23.
citation: Thiruganasambandamoorthy V, Kwong K, Wells GA, Sivilotti MLA, Mukarram M, Rowe BH, Lang E, Perry JJ, Sheldon R, Stiell IG, Taljaard M. Development of the Canadian Syncope Risk Score to predict serious adverse events after emergency department assessment of syncope. CMAJ. 2016 Sep 6;188(12):E289-E298. doi: 10.1503/cmaj.151469. Epub 2016 Jul 4.
citation: Wongtanasarasin W, Nishijima DK, Wood N, DeAngelis J, Storrow A, Schimmel J, Beltre N, Sacco D, Probst MA. Factors associated with incentive redemption among participants in a multicenter prospective syncope clinical study. Acad Emerg Med. 2024 Dec;31(12):1276-1279. doi: 10.1111/acem.14979. Epub 2024 Jun 28. No abstract available.