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

RECRUITINGN/ASponsored by Wake Forest University Health Sciences
Actively Recruiting
PhaseN/A
SponsorWake Forest University Health Sciences
Started2023-10-02
Est. completion2026-09
Eligibility
Age21 Years+
Healthy vol.Accepted
Locations3 sites

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

Age: 21 Years+Healthy volunteers accepted
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

Conditions2

Chest PainHeart Disease

Locations3 sites

Michigan

1 site
Henry Ford Hospital
Detroit, Michigan, 48202

North Carolina

2 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Lauren Koehler

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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