Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

CARE-CP (Testa en kardiovaskulär ambulatorisk snabb utvärdering för patienter med bröstsmärta) (CARE-CP)

29 september 2026 uppdaterad av: Wake Forest University Health Sciences

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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

502

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Michigan
      • Detroit, Michigan, Förenta staterna, 48202
        • Rekrytering
        • Henry Ford Hospital
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28203
        • Rekrytering
        • Carolinas Medical Center
      • Winston-Salem, North Carolina, Förenta staterna, 27157

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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.

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

Andra namn:
  • CARE-CP (Cardiovascular Ambulatory Rapid Evaluation)
Övrig: Hospitalization Evaluation

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

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hospital-free days (HFD) at 30-days post-randomization
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hospital-free days (HFD) at 1-year post-randomization
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Simon Mahler, MD, MS, Wake Forest University Health Sciences

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 oktober 2023

Primärt slutförande (Beräknad)

1 september 2027

Avslutad studie (Beräknad)

1 september 2028

Studieregistreringsdatum

Först inskickad

1 juni 2023

Först inskickad som uppfyllde QC-kriterierna

1 juni 2023

Första postat (Faktisk)

9 juni 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 september 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera