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Emergency Response System Improvements for Cardiac Arrest

N/A
Waitlist Available
Led By Christopher Granger, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have a pulse on arrival of EMS, where a successful defibrillation was previously administered by a bystander or first responder
OHCA of non-traumatic etiology
Must not have
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
Bystander suspected cardiac arrest, where ROSC was achieved without the need for defibrillation or first responder CPR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to improve outcomes for people who have a cardiac arrest outside of a hospital. It will enroll 50 counties in North Carolina, which are estimated to have a total of approximately 20,000 patients with cardiac arrest over a 4-year intervention period. The trial duration is 7 years.

Who is the study for?
The RACE-CARS trial is for patients who experience non-traumatic out-of-hospital cardiac arrest (OHCA) and are pulseless when first responders arrive or become pulseless in their presence. It's not for cases where resuscitation isn't attempted due to severe injuries, signs of death, decomposition, or a valid DNR order.
What is being tested?
This study tests a system-wide intervention in 50 North Carolina counties to improve cardiac arrest outcomes. It includes rapid EMS dispatch, optimized first responder actions like early AED use, community CPR/AED training, and systematic bystander instruction by 911 operators.
What are the potential side effects?
Since this trial focuses on emergency response systems rather than medications, there aren't traditional side effects. However, participants may experience varying levels of physical stress from CPR or defibrillation if they're resuscitated during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was revived by a defibrillator before EMS arrived.
Select...
My cardiac arrest was not caused by an injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a cardiac arrest without attempted resuscitation due to severe injuries or signs of death.
Select...
I was revived from a suspected heart attack without needing shocks or CPR from first responders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge
Other study objectives
Change in Neurologic disability as measured by Modified Rankin Score
Change in Quality of life as measured by the EQ-5D-5L
Change in Quality of life as measured by the SF-36

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (Enhanced Standard of Care)Experimental Treatment4 Interventions
Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
Group II: Control (Standard of Care)Active Control1 Intervention
Usual care, continuing standard quality improvement effort

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,931 Previous Clinical Trials
47,746,708 Total Patients Enrolled
Duke UniversityLead Sponsor
2,454 Previous Clinical Trials
2,951,704 Total Patients Enrolled
Christopher Granger, MDPrincipal InvestigatorDuke University
4 Previous Clinical Trials
1,808 Total Patients Enrolled

Media Library

Comprehensive community training of lay people in CPR and AED use. Clinical Trial Eligibility Overview. Trial Name: NCT04660526 — N/A
Heart Attack Research Study Groups: Intervention (Enhanced Standard of Care), Control (Standard of Care)
Heart Attack Clinical Trial 2023: Comprehensive community training of lay people in CPR and AED use. Highlights & Side Effects. Trial Name: NCT04660526 — N/A
Comprehensive community training of lay people in CPR and AED use. 2023 Treatment Timeline for Medical Study. Trial Name: NCT04660526 — N/A
~10508 spots leftby Jun 2027
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