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RECRUITING Not applicable ClinicalTrials.gov

CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain)

Sponsor: Wake Forest University Health Sciences • ClinicalTrials.gov ID: NCT05897632

Registry updated: 2026-09-30
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Description

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.

Interventions

  • Outpatient Evaluation (Behavioral)
    Subjects will receive an outpatient evaluation within 72 of being discharged from the ED.
  • Hospitalization Evaluation (Behavioral)
    Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.

Eligibility criteria

Inclusion Criteria: * Age ≥21 years old * Chest pain or Symptoms of acute coronary syndrome (ACS) * Moderate risk of ACS (all of the below) * Hear Score 4-6 * Non-Ischemic electrocardiogram (ECG) * Two Troponin measures \< Sex-Specific Upper Reference Limit * Women \<15 pg/ml * Men \<20 pg/ml * No prior coronary artery disease (CAD) * No Prior Myocardial Infarction (MI) * No Prior Coronary Revascularization Procedures * No Patients with ≥ 70% Obstructive Coronary Disease Exclusion Criteria: * ST Elevation Myocardial Infarction (STEMI) Activation * ST Changes or new T-wave inversions ≥1mm on ECG * Any Elevated Troponin Measure (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 (CCTA), Invasive Coronary Angiography (Cardiac Cath) within 1 year * "Clean" CCTA or Cardiac Cath (0% stenosis in all vessels) within the past 2 years * Chest Trauma * Pregnancy * Life Expectancy \< 1 year * Other comorbid conditions requiring hospitalization * Unstable Vitals (Blood Pressure \<90, Heart Rate \>120 or \<50, O2 Sat \<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 * Already Enrolled in Other Interventional Trial

Conditions

Chest Pain

Locations

  • Henry Ford Hospital — Detroit, Michigan, United States
  • Carolinas Medical Center — Charlotte, North Carolina, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record