RecruitingNot ApplicableNCT05897632

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

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


Sponsor

Wake Forest University Health Sciences

Enrollment

502 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 Years

Inclusion Criteria12

  • 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 Criteria17

  • 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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Interventions

BEHAVIORALOutpatient Evaluation

Subjects will receive an outpatient evaluation within 72 of being discharged from the ED.

BEHAVIORALHospitalization Evaluation

Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.


Locations(3)

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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NCT05897632


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