SyncopePACESNCT04533425
Practical Approaches to Care in Emergency Syncope
An observational study of Syncope and Presyncope, run by Columbia University at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Syncope, Presyncope
- How many people
- 1,297 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Sep 2020to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6574
Columbia University Irving Medical Center
New York, New York, 10032
University of Rochester
Rochester, New York, 14642
UC Davis
Sacramento, California, 95817
About this study
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
Read the 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.
- Conditions
- Syncope, Presyncope
- Keywords
- Risk Score, Risk Stratification, External Validation
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with syncope | Patients who present to the ED with syncope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start14 Sep 2020
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marc Probst, Columbia University
- Investigators
- Marc A Probst, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533425
- Sponsor's protocol ID
- AAAT5903
- Other IDs
- R01HL149680, GCO 19-0127
- Acronym
- PACES
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25943042Probst 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.
PubMed 31668571Thiruganasambandamoorthy 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.
PubMed 27378464DeAngelis J, Vargas G, Weiss RE, Winskill C, Suh EH, Sacco DL, Wood N, Nishijima DK, Storrow AB, Schimmel J, Poterucha TJ, Elias PA, Beltre N, Probst MA. Predicting Echocardiography Findings in Adults Presenting to the Emergency Department With Syncope: An External Validation of the ROMEO Score. Acad Emerg Med. 2026 Jun;33(6):e70366. doi: 10.1111/acem.70366.
PubMed 42340085Suh EH, Sacco DL, Winskill C, DeAngelis J, Nishijima D, Schimmel J, Storrow A, Thiruganasambandamoorthy V, Weiss RE, Wood N, Probst MA. Serious Cardiac Outcomes and Physician Estimation of Risk in Emergency Department Patients With Presyncope Versus Syncope. Ann Emerg Med. 2026 Jan;87(1):69-78. doi: 10.1016/j.annemergmed.2025.08.014. Epub 2025 Sep 23.
PubMed 40990887Sacco DL, Suh EH, Winskill C, Wan EY, DeAngelis J, Nishijima DK, Schimmel J, Storrow AB, Thiruganasambandamoorthy V, Wood N, Weiss RE, Probst MA. Sex Differences in Clinical Outcomes and Resource Utilization Among Emergency Department Patients With Unexplained Syncope or Presyncope: A Prospective, Observational, Cohort Study. Ann Emerg Med. 2026 Aug;88(2):154-165. doi: 10.1016/j.annemergmed.2026.01.020. Epub 2026 Mar 19.
PubMed 41860508Baugh CW, Winskill C, Suh EH, Sacco DL, DeAngelis J, Nishijima DK, Schimmel J, Storrow AB, Wood N, Weiss RE, Probst MA. Diagnostic Yield of Hospitalization for Emergency Department Patients With Syncope and Presyncope. Acad Emerg Med. 2026 Aug;33(8):e70393. doi: 10.1111/acem.70393.
PubMed 42573572Suh EH, Winskill C, Sacco DL, DeAngelis J, Nishijima DK, Schimmel J, Storrow AB, Wood NE, Thiruganasambandamoorthy V, Baugh CW, Weiss RE, Probst MA. Validation of 2 Syncope Risk Scores and Comparison With Physician Risk Estimation. JAMA Netw Open. 2026 May 1;9(5):e2617362. doi: 10.1001/jamanetworkopen.2026.17362.
PubMed 42154462Wongtanasarasin 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.
PubMed 38940329
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Approaches to Care in Emergency Syncope
- ClinicalTrials.gov ID
- NCT04533425
- Acronym / sponsor ID
- PACES / AAAT5903
- Conditions
- Syncope, Presyncope
- Keywords
- Risk Score, Risk Stratification, External Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,297 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with syncope | – | –Patients who present to the ED with syncope |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
US Syncope Risk Score (The FAINT Score)
Time frame: 30 days
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.
Canadian Syncope Risk Score
Time frame: 30 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 25943042Probst 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.
- Background: PubMed 31668571Probst 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.
- Background: PubMed 27378464Thiruganasambandamoorthy 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.
- Results publication: PubMed 42340085DeAngelis J, Vargas G, Weiss RE, Winskill C, Suh EH, Sacco DL, Wood N, Nishijima DK, Storrow AB, Schimmel J, Poterucha TJ, Elias PA, Beltre N, Probst MA. Predicting Echocardiography Findings in Adults Presenting to the Emergency Department With Syncope: An External Validation of the ROMEO Score. Acad Emerg Med. 2026 Jun;33(6):e70366. doi: 10.1111/acem.70366.
- Results publication: PubMed 40990887Suh EH, Sacco DL, Winskill C, DeAngelis J, Nishijima D, Schimmel J, Storrow A, Thiruganasambandamoorthy V, Weiss RE, Wood N, Probst MA. Serious Cardiac Outcomes and Physician Estimation of Risk in Emergency Department Patients With Presyncope Versus Syncope. Ann Emerg Med. 2026 Jan;87(1):69-78. doi: 10.1016/j.annemergmed.2025.08.014. Epub 2025 Sep 23.
- Results publication: PubMed 41860508Sacco DL, Suh EH, Winskill C, Wan EY, DeAngelis J, Nishijima DK, Schimmel J, Storrow AB, Thiruganasambandamoorthy V, Wood N, Weiss RE, Probst MA. Sex Differences in Clinical Outcomes and Resource Utilization Among Emergency Department Patients With Unexplained Syncope or Presyncope: A Prospective, Observational, Cohort Study. Ann Emerg Med. 2026 Aug;88(2):154-165. doi: 10.1016/j.annemergmed.2026.01.020. Epub 2026 Mar 19.
- Results publication: PubMed 42573572Baugh CW, Winskill C, Suh EH, Sacco DL, DeAngelis J, Nishijima DK, Schimmel J, Storrow AB, Wood N, Weiss RE, Probst MA. Diagnostic Yield of Hospitalization for Emergency Department Patients With Syncope and Presyncope. Acad Emerg Med. 2026 Aug;33(8):e70393. doi: 10.1111/acem.70393.
- Results publication: PubMed 42154462Suh EH, Winskill C, Sacco DL, DeAngelis J, Nishijima DK, Schimmel J, Storrow AB, Wood NE, Thiruganasambandamoorthy V, Baugh CW, Weiss RE, Probst MA. Validation of 2 Syncope Risk Scores and Comparison With Physician Risk Estimation. JAMA Netw Open. 2026 May 1;9(5):e2617362. doi: 10.1001/jamanetworkopen.2026.17362.
- Results publication: PubMed 38940329Wongtanasarasin 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.
- Complete bibliographyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc A Probst, MD, MS principal investigator
Columbia University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Presyncope, run by Columbia University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
US Syncope Risk Score (The FAINT Score) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04533425, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.