Cardiac ArrestNCT04660526
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
A study testing Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators, Systematic bystander resuscitation instruction by 911 operators and Comprehensive community training of lay people in CPR and AED use. in people with Cardiac Arrest, run by Duke University at 1 site in United States.
Trial summary
RACE-CARS is a real-world cluster-randomized trial designed to evaluate a multifaceted community and health systems intervention aimed to improve outcomes of out-of-hospital cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators, Systematic bystander resuscitation instruction by 911 operators and Comprehensive community training of lay people in CPR and AED use.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- OHCA of non-traumatic etiology
- Patients who are pulseless on arrival of a first responder; or patients who become pulseless in the presence of a first responder; OR patients who have a pulse on arrival of EMS, where a successful defibrillation was previously administered by a bystander or first responder.
Who cannot join
- Untreated cardiac arrests, including arrests in which resuscitation efforts are not initiated or are terminated immediately upon arrival of EMS because the patient is not a viable candidate for resuscitation due to:
- injuries incompatible with life,
- the presence of rigor mortis or lividity,
- signs of decomposition, or
- the presence of a valid DNR.
- Private EMS transport that did not involve 911 dispatch (example: interfacility transport between nursing home and hospital).
- Arrest of clear and obvious traumatic etiology
- Bystander suspected cardiac arrest, where ROSC was achieved without the need for defibrillation or first responder CPR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RAndomized Cluster Evaluation of Cardiac ARrest Systems
RACE-CARS is a real-world cluster-randomized trial designed to evaluate a multifaceted community and health systems intervention aimed to improve outcomes of out-of-hospital cardiac arrest. RACE-CARS will enroll 50 counties in North Carolina that are estimated to have a total of approximately 20,000 patients with cardiac arrest over a 4-year intervention period. County "clusters" will be randomized in a 1:1 ratio to intervention versus usual care. The trial duration is 7 years, which includes a 6-month start-up (including recruitment and randomization) period, a 12-month intervention training phase, a 4-year intervention period, a 12-month follow-up for to assess quality of life in survivors of OHCA, and a 6-month close-out and data analysis period.
- Conditions
- Cardiac Arrest
- Being tested
- Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators, Systematic bystander resuscitation instruction by 911 operators, Comprehensive community training of lay people in CPR and AED use., Optimized first responder performance including earlier use of AEDs.
- Keywords
- cardiac arrest, cardiopulmonary resuscitation, telephone CPR, dispatch CPR, out-of-hospital cardiac arrest, defibrillation
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operatorsOther
EMS first responders will recognize cardiac arrest and respond immediately, increasing time to dispatch
Systematic bystander resuscitation instruction by 911 operatorsOther
911 operators will be able to describe how to administer CPR over the phone.
Comprehensive community training of lay people in CPR and AED use.Other
Training of lay people regarding CPR and AED use.
Optimized first responder performance including earlier use of AEDs.Other
First responders will recognize where AEDs are located and use them appropriately
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Enhanced Standard of Care) | Experimental | Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance Receives: Other: Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators; Other: Systematic bystander resuscitation instruction by 911 operators; Other: Comprehensive community training of lay people in CPR and AED use.; Other: Optimized first responder performance including earlier use of AEDs. |
| Control (Standard of Care) | No intervention | Usual care, continuing standard quality improvement effort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge
Cerebral Performance Category (CPC)
Measured: up to 12months
Secondary outcomes (2)
Percent of patients who receive CPR from a bystander as measured by EMS report
Measured: Baseline
Rate of Defibrillation before paramedics arrive as measured by bystander interview
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Jul 2022
- Primary completion30 Sep 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Duke 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christopher Granger, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660526
- Sponsor's protocol ID
- Pro00105633
- Other IDs
- 5UH3HL146935-06, 5U24HL146938-06
- Status last verified
- Jul 2026
- First submitted
- 3 Dec 2020
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krychtiuk KA, Starks MA, Al-Khalidi HR, Mark DB, Monk L, Yow E, Kaltenbach L, Jollis JG, Al-Khatib SM, Bosworth HB, Ward K, Brady S, Tyson C, Vandeventer S, Baloch K, Oakes M, Blewer AL, Lewinski AA, Hansen CM, Sharpe E, Rea TD, Nelson RD, Sasson C, McNally B, Granger CB; RACE-CARS NC Counties. RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design. Am Heart J. 2024 Nov;277:125-137. doi: 10.1016/j.ahj.2024.07.013. Epub 2024 Jul 30.
PubMed 39084483
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAndomized Cluster Evaluation of Cardiac ARrest Systems
- ClinicalTrials.gov ID
- NCT04660526
- Acronym / sponsor ID
- Pro00105633
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, cardiopulmonary resuscitation, telephone CPR, dispatch CPR, out-of-hospital cardiac arrest, defibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Dec 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.
RACE-CARS is a real-world cluster-randomized trial designed to evaluate a multifaceted community and health systems intervention aimed to improve outcomes of out-of-hospital cardiac arrest. RACE-CARS will enroll 50 counties in North Carolina that are estimated to have a total of approximately 20,000 patients with cardiac arrest over a 4-year intervention period. County "clusters" will be randomized in a 1:1 ratio to intervention versus usual care. The trial duration is 7 years, which includes a 6-month start-up (including recruitment and randomization) period, a 12-month intervention training phase, a 4-year intervention period, a 12-month follow-up for to assess quality of life in survivors of OHCA, and a 6-month close-out and data analysis period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Enhanced Standard of Care) | Experimental | Other: Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators, Other: Systematic bystander resuscitation instruction by 911 operators, Other: Comprehensive community training of lay people in CPR and AED use., Other: Optimized first responder performance including earlier use of AEDs.Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance |
| Control (Standard of Care) | No intervention | –Usual care, continuing standard quality improvement effort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OHCA of non-traumatic etiology
- Patients who are pulseless on arrival of a first responder; or patients who become pulseless in the presence of a first responder; OR patients who have a pulse on arrival of EMS, where a successful defibrillation was previously administered by a bystander or first responder.
Key exclusion criteria (8 listed)
- Untreated cardiac arrests, including arrests in which resuscitation efforts are not initiated or are terminated immediately upon arrival of EMS because the patient is not a viable candidate for resuscitation due to:
- Private EMS transport that did not involve 911 dispatch (example: interfacility transport between nursing home and hospital).
- Arrest of clear and obvious traumatic etiology
- Bystander suspected cardiac arrest, where ROSC was achieved without the need for defibrillation or first responder CPR
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 |
|---|---|---|
| Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operatorsEMS first responders will recognize cardiac arrest and respond immediately, increasing time to dispatch | Other | Intervention (Enhanced Standard of Care) |
| Systematic bystander resuscitation instruction by 911 operators911 operators will be able to describe how to administer CPR over the phone. | Other | Intervention (Enhanced Standard of Care) |
| Comprehensive community training of lay people in CPR and AED use.Training of lay people regarding CPR and AED use. | Other | Intervention (Enhanced Standard of Care) |
| Optimized first responder performance including earlier use of AEDs.First responders will recognize where AEDs are located and use them appropriately | Other | Intervention (Enhanced Standard of Care) |
Primary outcome
Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge
Time frame: up to 12months
Cerebral Performance Category (CPC)
2 secondary outcomes
Percent of patients who receive CPR from a bystander as measured by EMS report
Time frame: Baseline
Rate of Defibrillation before paramedics arrive as measured by bystander interview
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Derived from this study: PubMed 39084483Krychtiuk KA, Starks MA, Al-Khalidi HR, Mark DB, Monk L, Yow E, Kaltenbach L, Jollis JG, Al-Khatib SM, Bosworth HB, Ward K, Brady S, Tyson C, Vandeventer S, Baloch K, Oakes M, Blewer AL, Lewinski AA, Hansen CM, Sharpe E, Rea TD, Nelson RD, Sasson C, McNally B, Granger CB; RACE-CARS NC Counties. RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design. Am Heart J. 2024 Nov;277:125-137. doi: 10.1016/j.ahj.2024.07.013. Epub 2024 Jul 30.
- Individual participant dataSharing planned: No
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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.
Christopher Granger, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators, Systematic bystander resuscitation instruction by 911 operators and Comprehensive community training of lay people in CPR and AED use. in people with Cardiac Arrest, run by Duke University 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 2 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 28 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge (time frame: up to 12months). 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 NCT04660526, which also lists 1 linked publication.
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 28 Oct 2026.