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Search / Trial NCT05897632

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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 1, 2023

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Acute Coronary Syndrome Cardiovascular Diseases

ClinConnect Summary

The CARE-CP trial is studying the best way to evaluate patients who come to the emergency department with chest pain and are at moderate risk for serious heart issues, known as acute coronary syndrome (ACS). The researchers want to find out if it is better for these patients to be evaluated quickly as outpatients or to be admitted to the hospital. The goal is to see which method is safer, more efficient, and meets the needs of patients better.

To be eligible for this study, participants must be at least 21 years old and have chest pain or symptoms of ACS. They should have a specific risk score and certain test results that indicate they are at moderate risk, without having a history of severe heart disease. If you join the trial, you will be randomly assigned to either receive outpatient care or to be hospitalized for further evaluation. Throughout the trial, participants will be monitored closely to ensure their safety and well-being. This study is currently recruiting participants, and everyone, regardless of gender, is welcome to join as long as they meet the eligibility criteria.

Gender

ALL

Eligibility criteria

  • 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

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Detroit, Michigan, United States

Winston Salem, North Carolina, United States

Charlotte, North Carolina, United States

Detroit, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Simon Mahler, MD, MS

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported