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RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

RAndomized Cluster Evaluation of Cardiac ARrest Systems

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04660526
Enrollment
20000
Registered
2020-12-09
Start date
2022-07-01
Completion date
2027-06-30
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

cardiac arrest, cardiopulmonary resuscitation, telephone CPR, dispatch CPR, out-of-hospital cardiac arrest, defibrillation

Brief 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. 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.

Interventions

OTHERRapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators

EMS first responders will recognize cardiac arrest and respond immediately, increasing time to dispatch

OTHERSystematic bystander resuscitation instruction by 911 operators

911 operators will be able to describe how to administer CPR over the phone.

OTHERComprehensive community training of lay people in CPR and AED use.

Training of lay people regarding CPR and AED use.

OTHEROptimized first responder performance including earlier use of AEDs.

First responders will recognize where AEDs are located and use them appropriately

Sponsors

Duke University
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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: 1. injuries incompatible with life, 2. the presence of rigor mortis or lividity, 3. signs of decomposition, or 4. 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

Design outcomes

Primary

MeasureTime frameDescription
Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at dischargeup to 12monthsCerebral Performance Category (CPC)

Secondary

MeasureTime frame
Percent of patients who receive CPR from a bystander as measured by EMS reportBaseline
Rate of Defibrillation before paramedics arrive as measured by bystander interviewBaseline

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChristopher Granger, MD

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026