Recruiting

CARE-CP

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05897632

Conditions

Chest Pain

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Outpatient Evaluation

Hospitalization Evaluation

Study Details

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.

Conditions

Chest Pain

Study ID

NCT05897632

Start date

Oct 2, 2023

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not 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

Study Design

Enrollment

502 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Outpatient Evaluation

Patients randomized to this arm are discharged and receive outpatient evaluation, or cardiovascular ambulatory rapid evaluation (CARE), focused on medical management for cardiovascular risk factors (e.g. hypertension) within 72 hours of Emergency Department discharge.

other: Hospitalization Evaluation

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

Interventions

Outpatient Evaluation

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

Hospitalization Evaluation

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

Primary outcome measure

  • Hospital-free days (HFD) at 30-days post-randomization [ Time Frame: Day 30 ]

Central Contacts and Locations

Central contacts

Lauren Koehler

336-716-4646Lauren.Koehler@Advocatehealth.org

Locations

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Lauren Koehler

Lauren.Koehler@Advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Keywords

  • Acute Coronary Syndrome
  • Cardiovascular Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-06.