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

NCT05897632 | Recruiting

• 1 other identifier: IRB00092604
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 3

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

Keywords

Acute Coronary Syndrome; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Hospital-free days (HFD) at 30-days post-randomization

  Time spent in a hospital setting at 30 days post-randomization will be measured and subtracted from time spent outside the hospital. Hospital time is broadly defined, based on a patient-centered definition of cumulative time spent in the ED, observation unit, or hospital ward. Consistent with prior trials, patients who experience death during the follow-up period are assigned zero HFDs.

  Day 30

Secondary Outcomes (15)

• Hospital-free days (HFD) at 1-year post-randomization

  Year 1

• Cardiovascular Hospital-free days (HFD) at 30-days post-randomization

  Day 30

• Cardiovascular Hospital-free days (HFD) at 1 year post-randomization

  Year 1

• Rate of noninvasive cardiac testing at 30-days post-randomization

  Day 30

• Rate of noninvasive cardiac testing at 1 year post-randomization

  Year 1

Study Arms (2)

Outpatient Evaluation

OTHER

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.

Behavioral: Outpatient Evaluation

Hospitalization Evaluation

OTHER

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

Behavioral: Hospitalization Evaluation

Interventions

Outpatient Evaluation BEHAVIORAL

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

Also known as: CARE-CP (Cardiovascular Ambulatory Rapid Evaluation)

Outpatient Evaluation

Hospitalization Evaluation BEHAVIORAL

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

Hospitalization Evaluation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (3)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Vascular Diseases

Study Officials

• Simon Mahler, MD, MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Koehler

CONTACT

336-716-4646; lekoehle@wakehealth.edu

Lauren Victory

CONTACT

336-716-7260; lvictory@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized with equal probability (1:1) to the outpatient arm or the hospitalization arms using permuted block randomization.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)