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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05897632
Status
Recruiting

Conditions

  • Chest Pain

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Outpatient Evaluation — BEHAVIORAL
    Subjects will receive an outpatient evaluation within 72 of being discharged from the ED.
  • Hospitalization Evaluation — BEHAVIORAL
    Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.

Study Details

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.

Key Dates

Start date
Oct 2, 2023
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
502 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Henry Ford HospitalDetroitMichigan48202-
Carolinas Medical CenterCharlotteNorth Carolina28203-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Lauren Koehler

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