Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT05897632

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

204 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

The goal of this study is to determine if rapid outpatient evaluation vs hospitalization management is the best strategy (based on patient-centered measures and safe, equitable, and efficient resource use) for evaluating patients with acute chest pain who are at moderate risk for acute coronary syndrome (ACS). Patients will be randomized in the Emergency Department to either an outpatient evaluation (CARE-CP) or hospitalization evaluation for their symptoms.

CONDITIONS

Official 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...

  • 21 years of age or older
  • Chest pain or symptoms of acute coronary syndrome (ACS)
  • Moderate risk of ACS with a Heart Score between 4 and 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 previous myocardial infarction or coronary revascularization procedures
  • No patients with 70% or greater obstructive coronary disease
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
  • "Clean" coronary CT angiogram or cardiac catheterization (0% stenosis in all vessels) within the past 2 years
  • Chest trauma
  • Pregnancy
  • Life expectancy less than 1 year
  • Other comorbid 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 (eGFR) <30 mL/min
  • Transfers from another hospital
  • Non-English speaking
  • Prisoners
  • Prior enrollment in this study
  • Already enrolled in another interventional trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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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