RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-02
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05897632

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥21 years old
  2. * Chest pain or Symptoms of acute coronary syndrome (ACS)
  3. * Moderate risk of ACS (all of the below)
  4. * Hear Score 4-6
  5. * Non-Ischemic electrocardiogram (ECG)
  6. * Two Troponin measures \< Sex-Specific Upper Reference Limit
  7. * Women \<15 pg/ml
  8. * Men \<20 pg/ml
  9. * No prior coronary artery disease (CAD)
  10. * No Prior Myocardial Infarction (MI)
  11. * No Prior Coronary Revascularization Procedures
  12. * No Patients with ≥ 70% Obstructive Coronary Disease
  1. * ST Elevation Myocardial Infarction (STEMI) Activation
  2. * ST Changes or new T-wave inversions ≥1mm on ECG
  3. * Any Elevated Troponin Measure (Based on Sex-Specific 99th Percentile)
  4. * Serial change between Troponin Measures (Delta) ≥5 pg/mL
  5. * Stress Echocardiography, Nuclear Stress Test, Stress ECG, Stress Cardiac MRI, Coronary CT Angiogram (CCTA), Invasive Coronary Angiography (Cardiac Cath) within 1 year
  6. * "Clean" CCTA or Cardiac Cath (0% stenosis in all vessels) within the past 2 years
  7. * Chest Trauma
  8. * Pregnancy
  9. * Life Expectancy \< 1 year
  10. * Other comorbid conditions requiring hospitalization
  11. * Unstable Vitals (Blood Pressure \<90, Heart Rate \>120 or \<50, O2 Sat \<90%)
  12. * End Stage Renal Disease; Dialysis or estimated glomerular filtration rate (eGFR) \<30 mL/min
  13. * Transfers From Another Hospital
  14. * Non-English Speaking
  15. * Prisoners
  16. * Prior Enrollment
  17. * Already Enrolled in Other Interventional Trial

Contacts and Locations

Study Contact

Lauren Koehler
CONTACT
336-716-4646
lekoehle@wakehealth.edu
Lauren Victory
CONTACT
336-716-7260
lvictory@wakehealth.edu

Principal Investigator

Simon Mahler, MD, MS
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Henry Ford Hospital
Detroit, Michigan, 48202
United States
Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Simon Mahler, MD, MS, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-10-02
Study Completion Date2026-10

Study Record Updates

Study Start Date2023-10-02
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Acute Coronary Syndrome
  • Cardiovascular Diseases

Additional Relevant MeSH Terms

  • Chest Pain