Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
ID05897632

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

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

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%
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at the Emergency Department

Outpatient Treatment

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

Hospitalization Treatment

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

Follow-up

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

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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

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