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

ConditionChest Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorWake Forest University Health Sciences

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

502 Participants
are divided into 2 treatment groups
Group A: Outpatient EvaluationOther 1 intervention
Group B: Hospitalization EvaluationOther 1 intervention

Trial outcomes

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.

Time frame
Day 30

Secondary outcomes

1

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

Time spent in a hospital setting at 1 year 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.

Time frame
Year 1
2

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

Rates of cardiovascular rehospitalizations at 30-days post-randomization will be analyzed between the two treatment arms.

Time frame
Day 30
3

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

Rates of cardiovascular rehospitalizations at 1 year post-randomization will be analyzed between the two treatment arms.

Time frame
Year 1
4

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

The rates of noninvasive testing (stress testing and coronary computed tomography angiography), at 30-days post-randomization will be analyzed between the two treatment arms.

Time frame
Day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Agency for Healthcare Research and Quality (AHRQ)

Collaborator