Actively Recruiting
CARE-CP Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain
Led by Wake Forest University Health Sciences · Updated on 2026-04-06
502
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
A
Agency for Healthcare Research and Quality (AHRQ)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the best way to evaluate patients who come to the Emergency Department with chest pain and are at moderate risk for acute coronary syndrome (ACS). The trial compares rapid outpatient evaluation to traditional hospitalization to see which approach is safer, more patient-centered, and uses healthcare resources more efficiently. This study is a prospective, randomized trial enrolling 502 patients to address gaps in current care practices for chest pain patients. Participants will be randomly assigned to one of two groups. One group will receive a rapid outpatient evaluation called CARE-CP, where patients are sent home from the Emergency Department and followed up in a clinic within 72 hours to manage heart-related risk factors and decide if further testing is needed. The other group will be hospitalized for evaluation in a ward, observation unit, or emergency department boarding. This design tests whether outpatient care can reduce hospital stays without compromising safety. During the study, participants will be monitored for hospital-free days over 30 days as the main outcome, with additional follow-up up to one year. Researchers will assess factors like repeat emergency visits, rehospitalizations, rates of cardiac testing, patient satisfaction, experience, and out-of-pocket costs. The study involves clinical evaluations, questionnaires, and billing data analysis to understand the best approach for moderate risk chest pain patients. Participation may last up to one year for some measures, ensuring thorough safety and effectiveness monitoring.
CONDITIONS
Brief Title
CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older
- Chest pain or symptoms of acute coronary syndrome (ACS)
- Moderate risk of ACS defined by Hear Score 4-6
- Non-ischemic electrocardiogram (ECG)
- Two troponin measurements below sex-specific upper reference limits (Women <15 pg/ml, Men <20 pg/ml)
- No prior coronary artery disease including no prior myocardial infarction or coronary revascularization
- No obstructive coronary disease ≥ 70%
You will not qualify if you...
- ST Elevation Myocardial Infarction (STEMI) activation
- ST changes or new T-wave inversions ≥1mm on ECG
- Any elevated troponin measurement based on sex-specific 99th percentile
- Serial change between troponin measures (Delta) ≥5 pg/mL
- Stress echocardiography, nuclear stress test, stress ECG, stress cardiac MRI, coronary CT angiogram, or invasive coronary angiography within 1 year
- Normal coronary CT angiogram or cardiac catheterization within past 2 years
- Chest trauma
- Pregnancy
- Life expectancy less than 1 year
- Other conditions requiring hospitalization
- Unstable vital signs (blood pressure <90, heart rate >120 or <50, oxygen saturation <90%)
- End stage renal disease, dialysis, or estimated glomerular filtration rate <30 mL/min
- Transfers from another hospital
- Non-English speaking
- Prisoners
- Prior enrollment in this trial
- Currently enrolled in another interventional trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the Emergency Department
Duration - Up to 3 days
Participants randomized to the outpatient evaluation arm are discharged from the Emergency Department and receive an outpatient cardiovascular ambulatory rapid evaluation focused on medical management for cardiovascular risk factors within 72 hours.
1 outpatient follow-up visit within 72 hours of discharge
Duration - Duration of hospital stay as per clinical care
Participants randomized to the hospitalization evaluation arm receive their chest pain evaluation in a hospital ward, observation unit, or emergency department boarding.
Hospitalization period including continuous monitoring
Duration - Up to 1 year post-randomization
Participants are followed for outcomes including hospital-free days, cardiac testing, repeat emergency visits, rehospitalizations, patient satisfaction, and costs over a 30-day and 1-year period.
Assessments at 30 days and 1 year post-randomization
Trial Site Locations
Total: 3 locations
1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
2
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
3
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
L
Lauren Koehler
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here