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

NCT ID: NCT05897632

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2026-10-31

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.

Detailed Description

Current care patterns for the 7 million patients visiting Emergency Departments (EDs) in the United States with chest pain are heterogeneous and not sustainable from a healthcare quality or economic perspective. Chest pain is the second most common cause of ED visits and the most common reason for short-stay hospitalizations. During these hospitalizations patients undergo in-depth evaluations (stress testing, computed tomography coronary angiography, or invasive angiography), but ultimately <10% are diagnosed with acute coronary syndrome (ACS). These evaluations cost $3 billion annually and strain health system resources without clear evidence of improved health outcomes or patient experience. The preliminary data suggest that moderate risk patients (35% of patients with chest pain) can be safely managed as outpatients using a cardiovascular ambulatory rapid evaluation (CARE-CP) strategy as an alternative to hospitalization. In the CARE-CP strategy, patients are discharged from the ED and receive outpatient clinic follow-up within 72 hours focused on medical management for cardiovascular risk factors (e.g., hypertension, diabetes) and determining whether further cardiac testing is needed. This strategy aims to enhance patient-centered outcomes while safely and equitably decreasing hospital resource utilization. However, equipoise exists between outpatient and hospitalization strategies for moderate risk patients. There is a paucity of prospective data evaluating the efficacy and patient-centeredness of outpatient chest pain evaluation strategies in moderate risk patients. Thus, it is unclear whether use of an outpatient chest pain management strategy (CARE-CP) will safely reduce healthcare utilization and be preferred by patients compared to a traditional hospitalization strategy. To address this key evidence gap, the study proposes the first prospective multisite randomized trial testing outpatient vs hospitalization strategies in moderate risk patients. The research teams will randomize 502 patients 1:1 to the CARE-CP or hospitalization management arms at three ED sites with a history of high recruitment rates and productive collaborations in cardiovascular clinical trials. The primary outcome will be hospital-free days (HFD) over a 30-day period. This novel trial addresses a key evidence gap by providing guidance on how best to evaluate moderate risk ED patients with acute chest pain. Without this guidance care patterns are likely to remain heterogeneous, inefficient, non-patient-centered, and unguided by the highest level of evidence. We hypothesize that data from this trial will support widespread implementation of a CARE-CP strategy, which could improve the quality and value of care for millions of patients in the U.S. and beyond.

Conditions

Chest Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Outpatient Evaluation

Intervention Type: BEHAVIORAL

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.

Group Type: OTHER

Hospitalization Evaluation

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Hospitalization Evaluation

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

Intervention Type: BEHAVIORAL

Other Intervention Names

CARE-CP (Cardiovascular Ambulatory Rapid Evaluation)

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
• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Mahler, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Site Status: RECRUITING

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status: RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren Koehler

Role: CONTACT

lekoehle@wakehealth.edu

336-716-4646

Lauren Victory

Role: CONTACT

lvictory@wakehealth.edu

336-716-7260

Facility Contacts

Lauren Koehler

Role: primary

Other Identifiers

IRB00092604

Identifier Type: -

Identifier Source: org_study_id