A Study of Elecsys® Troponin T Hs Gen 6 in Participants with Symptoms of Acute Coronary Syndrome
- Conditions
- Registration Number
- NCT06734117
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This prospective, non-interventional, single arm, longitudinal cohort multicenter study will recruit approximately 5600 consecutive all-comers, consisting of patients with signs and symptoms of acute coronary syndromes (ACS) who present in the emergency department (ED). The main objective of the study is to determine the clinical performance of Elecsys Tropo...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5429
-
Age ≥20 years
-
Signed Informed Consent Form
-
Troponin or other cardiac marker determination planned as part of suspected acute coronary syndromes routine care
-
Demonstrating symptoms suggestive of acute coronary syndrome and/or myocardial ischemia, such as any of the following:
- Chest pain, pressure, or a burning sensation across the precordium and epigastrium;
- Pain that radiates to neck, shoulder, jaw, back, upper abdomen, or either arm;
- Acute onset or worsening dyspnea;
- Nausea, vomiting or indigestion;
- Lightheadedness or syncope;
- Diaphoresis;
- Generalized weakness or fatigue;
-
OR, asymptomatic subjects or patients with atypical symptoms in whom myocardial infarction is being suspected.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Timepoint T3aid T3aid (121 to 240 minutes) after participant presentation at the emergency department The sensitivity of a diagnostic test is the percentage of true positive (TP) tests out of all patients with a condition. It is calculated as follows: (TP)/(TP + false negatives (FN))\*100%.
- Secondary Outcome Measures
Name Time Method Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints T0aid (0 to 60 minutes), T1aid (61 to 120 minutes), T5aid (241 to 360 minutes), and T6+aid (>360 minutes) after participant presentation at the emergency department The sensitivity of a diagnostic test is the percentage of true positive tests out of all patients with a condition. It is calculated as follows: (TP)/(TP + FN)\*100%.
Specificity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints T0aid (0 to 60 minutes), T1aid (61 to 120 minutes), T3aid (121 to 240 minutes), T5aid (241 to 360 minutes), and T6+aid (>360 minutes) after participant presentation at the emergency department The specificity of a diagnostic test is the percentage of true negative (TN) tests out of all patients who do not have a condition. It is calculated as follows: (TN)/(TN + false positives (FP))\*100%.
Negative Predictive Value of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints T0aid (0 to 60 minutes), T1aid (61 to 120 minutes), T3aid (121 to 240 minutes), T5aid (241 to 360 minutes), and T6+aid (>360 minutes) after participant presentation at the emergency department The negative predictive value of a diagnostic test is the percentage of true negative tests out of all of the negative findings. It is calculated as follows: (TN)/(TN + FN)\*100%.
Positive Predictive Value of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints T0aid (0 to 60 minutes), T1aid (61 to 120 minutes), T3aid (121 to 240 minutes), T5aid (241 to 360 minutes), and T6+aid (>360 minutes) after participant presentation at the emergency department The positive predictive value of a diagnostic test is the percentage of true positive tests out of all of the positive findings. It is calculated as follows: (TP)/(TP + FP)\*100%.
Negative Predictive Value of Fast Rule-Out of Myocardial Infarction Using Elecsys® Troponin T hs Gen 6 and the European Society of Cardiology 0/1-Hour Algorithm T0fast (0 to 60 minutes) after participant presentation at the emergency department and T1fast (30 to 90 minutes from T0fast sample) The negative predictive value of a diagnostic test is the percentage of true negative tests out of all of the negative findings. It is calculated as follows: (TN)/(TN + FN)\*100%.
Trial Locations
- Locations (28)
El Centro Regional Medical Center
🇺🇸El Centro, California, United States
UCSD La Jolla ED
🇺🇸La Jolla, California, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Parkview Research
🇺🇸Fort Wayne, Indiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Henry Ford Health
🇺🇸Detroit, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
University at Buffalo / Buffalo General Hospital
🇺🇸Buffalo, New York, United States
University of Buffalo - Erie County Medical Center
🇺🇸Buffalo, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Duke Regional Hospital
🇺🇸Durham, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Atrium Health Wake Forest Baptist, High Point Medical Center
🇺🇸High Point, North Carolina, United States
Wake Forest Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
MUSC Health Florence Medical Center
🇺🇸Florence, South Carolina, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Eastside Research Associates
🇺🇸Redmond, Washington, United States
MultiCare Institute for Research & Innovation
🇺🇸Tacoma, Washington, United States
Aspirus Medical Group
🇺🇸Wausau, Wisconsin, United States
Medical University Vienna
🇦🇹Vienna, Austria
MHAT "Heart and Brain"
🇧🇬Pleven, Bulgaria