Practical Approaches to Care in Emergency Syncope

NCT04533425 | Completed DMC

• 3 other identifiers: AAAT5903R01HL149680GCO 19-0127
• Study Type: observational
• Target: 1,297
• Locations: 1 country
• Sites: 5

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

Conditions

Syncope; Presyncope

Keywords

Risk Score; Risk Stratification; External Validation

Outcome Measures

Primary Outcomes (2)

• US Syncope Risk Score (The FAINT Score)

  A combination of clinical, electrocardiographic, and laboratory variables to predict the risk of serious clinical outcomes at 30 days. Full scale range from 0-6, higher score indicates higher risk of a serious cardiac event or death.

  30 days

• Canadian Syncope Risk Score

  A combination of clinical, electrocardiographic, and laboratory variables to predict the risk of serious clinical outcomes at 30 days. Full scale range from -3 to 11, higher score indicates higher risk of a serious clinical event or death.

  30 days

Study Arms (1)

Patients with syncope

Patients who present to the ED with syncope

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

UC Davis

Sacramento, California, 95817, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (4)

• 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.

  PMID: 25943042 BACKGROUND

• 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.

  PMID: 31668571 BACKGROUND

• 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.

  PMID: 27378464 BACKGROUND

• 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.

  PMID: 38940329 BACKGROUND

Related Links

• Complete bibliography

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for cardiac biomarker testing.

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc A Probst, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: August 31, 2020
• Study Start: September 14, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

US (5)