Chest PainRACE-ITNCT04488913
Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin
A study testing RACE-IT Pathway in people with Chest Pain and Myocardial Ischemia, run by Henry Ford Health System at 1 site in United States.
Trial summary
As part of the planned implementation of a new clinical pathway using hs-cTnI, the investigators will measure patient outcomes and clinical processes in a real-world scenario throughout an integrated health system across 9 emergency departments (ED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Myocardial Ischemia
- What is being tested?
- RACE-IT Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32,609 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2020to 3 Mar 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years old presenting to the ED for whom a treating clinician suspects ACS and orders a baseline ECG and cardiac troponin.
Who cannot join
- ST-segment Myocardial Infarction (STEMI) leading to immediate reperfusion therapy
- Any ED-drawn hs-cTnI value > 99th percentile (18 ng/L)
- Clear traumatic cause for symptoms (e.g., direct chest wall trauma, motor vehicle accident)
- A transfer from another facility
- Primary residence outside the state of Michigan
- Previous inclusion in the study
- Enrolled in hospice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Acute Coronary Syndrome Exclusion Using the Beckman Coulter Access High-sensitivity I Troponin
As part of the planned implementation of a new clinical pathway using hs-cTnI, the investigators will measure patient outcomes and clinical processes in a real-world scenario throughout an integrated health system across 9 emergency departments (ED).
Read the detailed description
This is a pragmatic, implementation study testing the implications of a real-world execution of a rapid evaluation pathway for suspected ACS using the Beckman hs-cTnI assay. As the new protocol is executed across 9 EDs within an integrated health system, the investigators will study its effects on patient and system-level metrics. A modified stepped wedge design will be utilized that allows comparison of the RACE-IT pathway with standard of care management
- Conditions
- Chest Pain, Myocardial Ischemia
- Being tested
- RACE-IT Pathway, Standard of Care
- Keywords
- high-sensitivity troponin, chest pain
- Medical subject headings
- Chest Pain, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RACE-IT PathwayOther
This care pathway includes the evaluation of suspected acute coronary syndrome with high-sensitivity troponin I testing and further prognostication as needed with a modified HEART score
Standard of CareOther
Standard of care protocol that uses the 99th percentile troponin values for evaluation of suspected acute coronary syndrome and further prognostication using the HEART score
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Treatment | Other | Exposure to traditional evaluation for suspected acute coronary syndrome (ACS) with ECG, 0- and 3-hour troponin testing using the 99th percentile as the upper reference limit, and application of the History, EKG, Age, Risk factors, and troponin (HEART) score. Receives: Other: Standard of Care |
| RACE-IT pathway | Active comparator | Exposure to new protocol for suspected ACS, which includes the use of 0- and 1-hour ECG and high-sensitivity troponin testing and application of the HEAR score (a modification of the HEART score) Receives: Other: RACE-IT Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe ED discharge
Proportion of patients with safe discharges home from the ED, defined as being without death or acute myocardial infarction within 30-days
Measured: 30 days after initial presentation
Secondary outcomes (5)
Length of hospital stay
Length of time from initial presentation to the Emergency Department until final discharge from the Emergency Department or Observation Unit
Measured: From date and time of start of emergency department encounter until date and time of end of ED or hospital encounter (whichever is latest), assessed up to 7 days.
Number of participants with death or acute myocardial infarction
Death or presence of acute myocardial infarction determined by adjudication panel
Measured: 30-day and through 1 year
Number of participants with revascularization or rehospitalization for cardiovascular disease
revascularization includes percutaneous coronary interventions and rehospitalization is inclusive of any such event for acute heart failure, acute myocardial infarction, or arrhythmia
Measured: 30-days
Composite number of cardiology resources utilized
Cardiology resources are inclusive of completed orders for cardiac stress tests, cardiology consultation, coronary computed tomography, coronary angiography, and percutaneous coronary intervention
Measured: 30-days
Hospital payments received
The total hospital payments received for the initial ED visit and any subsequent hospitalizations and procedures that are cardiology related over 30-days from the initial encounter.
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 posted28 Jul 2020
- Study start29 Jul 2020
- Primary completion3 Apr 2021
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-Wedge Cluster Randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32,609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Coulter, Inc.
- Responsible party
- Principal investigator, Joseph Miller, MD, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488913
- Sponsor's protocol ID
- pending
- Acronym
- RACE-IT
- Status last verified
- Mar 2022
- First submitted
- 19 Jul 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miller J, Cook B, Gunaga S, Fadel R, Gandolfo C, Emakhu J, Mills NL, Mahler S, Levy P, Parikh S, Krupp S, Hawatian K, Nour K, Klausner H, Gindi R, Hudson M, Perrotta G, Zweig B, Lanfear D, Kim H, Danagoulian S, Keerie C, Nassereddine H, Morton T, Affas Z, Husain A, McCord J; RACE-IT Research Group. Health Care Resource Utilization for Patients With Suspected Myocardial Infarction: A Secondary Analysis of the RACE-IT Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e256930. doi: 10.1001/jamanetworkopen.2025.6930.
PubMed 40279128Glintborg D, Moller JK, Rubin KH, Lidegaard O, T'Sjoen G, Larsen MJO, Hilden M, Lehmann Christensen L, Andersen MS. Mental and Physical Health Among Danish Transgender Persons Compared With Cisgender Persons. JAMA Netw Open. 2025 Apr 1;8(4):e257115. doi: 10.1001/jamanetworkopen.2025.7115.
PubMed 40272800Miller J, Cook B, Singh-Kucukarslan G, Tang A, Danagoulian S, Heath G, Khalifa Z, Levy P, Mahler SA, Mills N, McCord J. RACE-IT - Rapid Acute Coronary Syndrome Exclusion using the Beckman Coulter Access high-sensitivity cardiac troponin I: A stepped-wedge cluster randomized trial. Contemp Clin Trials Commun. 2021 Apr 23;22:100773. doi: 10.1016/j.conctc.2021.100773. eCollection 2021 Jun.
PubMed 34013092
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Acute Coronary Syndrome Exclusion Using the Beckman Coulter Access High-sensitivity I Troponin
- ClinicalTrials.gov ID
- NCT04488913
- Acronym / sponsor ID
- RACE-IT / pending
- Conditions
- Chest Pain, Myocardial Ischemia
- Keywords
- high-sensitivity troponin, chest pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32,609 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Beckman Coulter, Inc.
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 3 Apr 2021 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 28 Jul 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.
As part of the planned implementation of a new clinical pathway using hs-cTnI, the investigators will measure patient outcomes and clinical processes in a real-world scenario throughout an integrated health system across 9 emergency departments (ED).
Detailed description
This is a pragmatic, implementation study testing the implications of a real-world execution of a rapid evaluation pathway for suspected ACS using the Beckman hs-cTnI assay. As the new protocol is executed across 9 EDs within an integrated health system, the investigators will study its effects on patient and system-level metrics. A modified stepped wedge design will be utilized that allows comparison of the RACE-IT pathway with standard of care management
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-Wedge Cluster Randomized
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Treatment | Other | Other: Standard of CareExposure to traditional evaluation for suspected acute coronary syndrome (ACS) with ECG, 0- and 3-hour troponin testing using the 99th percentile as the upper reference limit, and application of the History, EKG, Age, Risk factors, and troponin (HEART) score. |
| RACE-IT pathway | Active comparator | Other: RACE-IT PathwayExposure to new protocol for suspected ACS, which includes the use of 0- and 1-hour ECG and high-sensitivity troponin testing and application of the HEAR score (a modification of the HEART score) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥18 years old presenting to the ED for whom a treating clinician suspects ACS and orders a baseline ECG and cardiac troponin.
Key exclusion criteria (7 listed)
- ST-segment Myocardial Infarction (STEMI) leading to immediate reperfusion therapy
- Any ED-drawn hs-cTnI value > 99th percentile (18 ng/L)
- Clear traumatic cause for symptoms (e.g., direct chest wall trauma, motor vehicle accident)
- A transfer from another facility
- Primary residence outside the state of Michigan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RACE-IT PathwayThis care pathway includes the evaluation of suspected acute coronary syndrome with high-sensitivity troponin I testing and further prognostication as needed with a modified HEART score | Other | RACE-IT pathway |
| Standard of CareStandard of care protocol that uses the 99th percentile troponin values for evaluation of suspected acute coronary syndrome and further prognostication using the HEART score | Other | Standard of Care Treatment |
Primary outcome
Safe ED discharge
Time frame: 30 days after initial presentation
Proportion of patients with safe discharges home from the ED, defined as being without death or acute myocardial infarction within 30-days
5 secondary outcomes
Length of hospital stay
Time frame: From date and time of start of emergency department encounter until date and time of end of ED or hospital encounter (whichever is latest), assessed up to 7 days.
Number of participants with death or acute myocardial infarction
Time frame: 30-day and through 1 year
Number of participants with revascularization or rehospitalization for cardiovascular disease
Time frame: 30-days
Composite number of cardiology resources utilized
Time frame: 30-days
Hospital payments received
Time frame: 30-days
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 23 Mar 2022.
- Derived from this study: PubMed 40279128Miller J, Cook B, Gunaga S, Fadel R, Gandolfo C, Emakhu J, Mills NL, Mahler S, Levy P, Parikh S, Krupp S, Hawatian K, Nour K, Klausner H, Gindi R, Hudson M, Perrotta G, Zweig B, Lanfear D, Kim H, Danagoulian S, Keerie C, Nassereddine H, Morton T, Affas Z, Husain A, McCord J; RACE-IT Research Group. Health Care Resource Utilization for Patients With Suspected Myocardial Infarction: A Secondary Analysis of the RACE-IT Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e256930. doi: 10.1001/jamanetworkopen.2025.6930.
- Derived from this study: PubMed 40272800Glintborg D, Moller JK, Rubin KH, Lidegaard O, T'Sjoen G, Larsen MJO, Hilden M, Lehmann Christensen L, Andersen MS. Mental and Physical Health Among Danish Transgender Persons Compared With Cisgender Persons. JAMA Netw Open. 2025 Apr 1;8(4):e257115. doi: 10.1001/jamanetworkopen.2025.7115.
- Derived from this study: PubMed 34013092Miller J, Cook B, Singh-Kucukarslan G, Tang A, Danagoulian S, Heath G, Khalifa Z, Levy P, Mahler SA, Mills N, McCord J. RACE-IT - Rapid Acute Coronary Syndrome Exclusion using the Beckman Coulter Access high-sensitivity cardiac troponin I: A stepped-wedge cluster randomized trial. Contemp Clin Trials Commun. 2021 Apr 23;22:100773. doi: 10.1016/j.conctc.2021.100773. eCollection 2021 Jun.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RACE-IT Pathway in people with Chest Pain and Myocardial Ischemia, run by Henry Ford Health System at 1 site 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 1 inclusion and 7 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 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Safe ED discharge (time frame: 30 days after initial presentation). 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 NCT04488913, which also lists 3 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 23 Mar 2022.