NCT05897632 CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain)
| NCT ID | NCT05897632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Chest Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 502 participants |
| Start Date | 2023-10-02 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 502 participants in total. It began in 2023-10-02 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Simon Mahler, MD, MS
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05897632 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Chest Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05897632 currently recruiting?
Yes, NCT05897632 is actively recruiting participants. Contact the research team at Lauren.Koehler@Advocatehealth.org for enrollment information.
Where is the NCT05897632 trial being conducted?
This trial is being conducted at Detroit, United States, Charlotte, United States, Winston-Salem, United States.
Who is sponsoring the NCT05897632 clinical trial?
NCT05897632 is sponsored by Wake Forest University Health Sciences. The principal investigator is Simon Mahler, MD, MS at Wake Forest University Health Sciences. The trial plans to enroll 502 participants.