NCT05897632 CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain)
| NCT ID | NCT05897632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Chest Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 502 participants |
| Start Date | 2023-10-02 |
| Primary Completion | 2026-09 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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