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

April 1, 2026 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
502

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center
      • Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Outpatient Evaluation
Subjects will receive an outpatient evaluation within 72 of being discharged from the ED.
Other Names:
  • CARE-CP (Cardiovascular Ambulatory Rapid Evaluation)
Other: Hospitalization Evaluation
Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.
Behavioral: Hospitalization Evaluation
Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital-free days (HFD) at 30-days post-randomization
Time Frame: Day 30
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital-free days (HFD) at 1-year post-randomization
Time Frame: Year 1
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.
Year 1
Cardiovascular Hospital-free days (HFD) at 30-days post-randomization
Time Frame: Day 30
Rates of cardiovascular rehospitalizations at 30-days post-randomization will be analyzed between the two treatment arms.
Day 30
Cardiovascular Hospital-free days (HFD) at 1 year post-randomization
Time Frame: Year 1
Rates of cardiovascular rehospitalizations at 1 year post-randomization will be analyzed between the two treatment arms.
Year 1
Rate of noninvasive cardiac testing at 30-days post-randomization
Time Frame: Day 30
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.
Day 30
Rate of noninvasive cardiac testing at 1 year post-randomization
Time Frame: Year 1
The rates of noninvasive testing (stress testing and coronary computed tomography angiography), at 1 year post-randomization will be analyzed between the two treatment arms.
Year 1
Rate of invasive cardiac testing at 30-days post-randomization
Time Frame: Day 30
The rates of invasive testing (coronary angiography), at 30-days post-randomization will be analyzed between the two treatment arms.
Day 30
Rate of invasive cardiac testing at 1 year post-randomization
Time Frame: Year 1
The rates of invasive testing (coronary angiography), at 1 year post-randomization will be analyzed between the two treatment arms.
Year 1
Cardiovascular repeat ED visits at 30-days post-randomization
Time Frame: Day 30
The rates of Cardiovascular repeat ED visits at 30-days post-randomization will be analyzed between the two treatment arms.The ED visit will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Day 30
Cardiovascular repeat ED visits at 1 year post-randomization
Time Frame: Year 1
The rates of Cardiovascular repeat ED visits at 1 year post-randomization will be analyzed between the two treatment arms.The ED visit will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Year 1
Cardiovascular rehospitalizations at 30-days post-randomization
Time Frame: Day 30
The rates of Cardiovascular rehospitalizations at 30-days post-randomization will be analyzed between the two treatment arms.The rehospitalization will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Day 30
Cardiovascular rehospitalizations at 1 year post-randomization
Time Frame: Year 1
The rates of Cardiovascular rehospitalizations at 1 year post-randomization will be analyzed between the two treatment arms.The rehospitalization will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.
Year 1
Patient satisfaction (SAPS questionnaire)
Time Frame: Day 30
Satisfaction will be assessed using the Short Assessment of Patient Satisfaction (SAPS). A patient satisfaction survey will be sent that evaluates clinician communication, participation in medical decision-making, respect by the clinician, clinician carefulness, time with the clinician, and treatment effect, in any service setting on a five-point Likert scale from "very dissatisfied" to "very satisfied". Scores from each item are summed and range from 0 (extremely dissatisfied) to 28 (extremely satisfied).
Day 30
Patient experience (GS-PEQ instrument)
Time Frame: Day 30
Experience will be measured using the Generic Short Patient Experience Questionnaire (GS-PEQ). A patient experience survey will also be sent out to evaluate which assesses timeliness and organization of medical services, confidence in the clinician and treatment, patient involvement in decision-making, clinician communication, patient outcomes, and incorrect treatment on a 5-point Likert-scale from "not at all" to "to a very large extent" and one question (on wait times) scored on a 4-point Likert scale from "no" to "yes, way too long. A mean score can be calculated for each patient, with higher scores indicating better experience.
Day 30
Out-of-pocket cost (based on billing data)
Time Frame: Day 30
Patient satisfaction, patient experience, and out-of-pocket costs will be measured in all trial participants. Financial records will be utilized from each site to determine patient billing, including the amount covered by insurance vs. patient responsibility. Each item will be measured in U.S. dollars and summed for total cost.
Day 30
Drivers of Patient Satisfaction and Experience (Qualitative)
Time Frame: Day 30
A subset of 100 patients (50 from each arm) will be purposively selected to ensure diversity in sex, race, ethnicity, socioeconomic status (SES), and health literacy for 30-minute semi-structured phone interviews to determine key drivers of patient satisfaction and experience. We will use an explanatory sequential mixed-methods design, in which participants' quantitative data will guide the collection and analysis of their qualitative data.These data will provide key context and meaning to the patient's quantitative response regarding patient satisfaction, experience, and out-of-pocket cost.
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agency for Healthcare Research and Quality (AHRQ)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simon Mahler, MD, MS, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00092604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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