Last updated: April 23, 2024
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting
Phase
N/A
Condition
Chest Pain
Treatment
Outpatient Evaluation
Hospitalization Evaluation
Clinical Study ID
NCT05897632
IRB00092604
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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, CoronaryCT 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) <30mL/min
- Transfers From Another Hospital
- Non-English Speaking
- Prisoners
- Prior Enrollment
- Already Enrolled in Other Interventional Trial
Study Design
Total Participants: 502
Treatment Group(s): 2
Primary Treatment: Outpatient Evaluation
Phase:
Study Start date:
October 02, 2023
Estimated Completion Date:
October 31, 2026
Study Description
Connect with a study center
Henry Ford Hospital
Detroit, Michigan 48202
United StatesActive - Recruiting
Carolinas Medical Center
Charlotte, North Carolina 28203
United StatesActive - Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
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