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

RecruitingNAAges 21 Years - anyAllWake Forest University Health Sciences
NCT05897632 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Outpatient Evaluation
  • Hospitalization Evaluation
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Where

3 sites
Henry Ford Hospital
Detroit, United States
Carolinas Medical Center
Charlotte, United States
Wake Forest University Health Sciences
Winston-Salem, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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