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| Name | Class |
|---|---|
| Roche Diagnostics GmbH | INDUSTRY |
| Roche Diagnostics Operations, Inc. | UNKNOWN |
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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 Troponin T hs Gen 6 versus the centrally adjudicated clinical diagnosis at various time points after ED presentation using the previously determined clinical cut-off of a universal 99th percentile upper reference limit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With Signs and Symptoms of Acute Coronary Syndromes | The study population will be a consecutive all-comers cohort consisting of patients with signs and symptoms of acute coronary syndromes presenting to the emergency department. Participants will be diagnosed and treated according to the local standard of care at the study site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elecsys® Troponin T hs Gen 6 | Diagnostic Test | It is an immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in human serum and plasma using cobas e platforms. This investigational immunoassay is intended to aid in the diagnosis of myocardial infarction. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Timepoint T3aid | 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%. | T3aid (121 to 240 minutes) after participant presentation at the emergency department |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints | 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%. | 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 |
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Inclusion Criteria:
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:
Exclusion Criteria:
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Approximately 5600 consecutive all-comers with signs and symptoms of acute coronary syndromes presenting to the emergency department.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Centro Regional Medical Center | El Centro | California | 92243 | United States | ||
| UCSD La Jolla ED |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41553478 | Derived | Daniels LB, Giannitsis E, Mueller C, Meex SJR, Buehlmann D, Kurtoic D, Bendig G, Cole M, Body R, Christenson RH, Cobbaert C, deFilippi CR, Eggers KM, Inoue K, Jaffe AS, McCarthy CP, McCord J, Neumann JT, Omland T, Papendick C, Sandoval Y, Tan JWC, Than MP, Twerenbold R, Mills NL, Peacock WF; TSIX investigators. Clinical performance of the next generation Elecsys Troponin T high-sensitivity Gen 6 assay in acute coronary syndrome (PERFORM-TSIX): study design. Clin Res Cardiol. 2026 Jan 19. doi: 10.1007/s00392-025-02842-x. Online ahead of print. |
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Plasma and serum samples
|
| Blood sample collection | Procedure | Blood will be collected from each recruited individual by a healthcare practitioner at five time points after emergency department presentation. |
|
| Specificity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints | 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%. | 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 |
| Negative Predictive Value of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints | 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%. | 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 |
| Positive Predictive Value of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints | 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%. | 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 |
| 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 | 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%. | T0fast (0 to 60 minutes) after participant presentation at the emergency department and T1fast (30 to 90 minutes from T0fast sample) |
| La Jolla |
| California |
| 92037 |
| United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Parkview Research | Fort Wayne | Indiana | 46845 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| University at Buffalo / Buffalo General Hospital | Buffalo | New York | 14203 | United States |
| University of Buffalo - Erie County Medical Center | Buffalo | New York | 14215 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| Atrium Health | Charlotte | North Carolina | 28203 | United States |
| Duke Regional Hospital | Durham | North Carolina | 27704 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Atrium Health Wake Forest Baptist, High Point Medical Center | High Point | North Carolina | 27262 | United States |
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73135-2607 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| MUSC Health Florence Medical Center | Florence | South Carolina | 29505 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| Baylor College of Medicine | Houston | Texas | 77030-2348 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Eastside Research Associates | Redmond | Washington | 98052 | United States |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | 98405 | United States |
| Aspirus Medical Group | Wausau | Wisconsin | 54401-4173 | United States |
| Medical University Vienna | Vienna | Austria |
| MHAT "Heart and Brain" | Burgas | Bulgaria |
| MHAT "Heart and Brain" | Pleven | Bulgaria |
| Peking University First Hospital | Beijing | China |
| Dongguan People's Hospital | Dongguan | China |
| Sun Yat-sen Memorial Hospital | Guangzhou | China |
| Shanghai Tongren Hospital | Shanghai | China |
| TEDA International Cardiovascular Hospital | Tianjin | China |
| Tongji Hospital | Wuhan | China |
| Zhongnan Hospital of Wuhan University | Wuhan | China |
| Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) | Berlin | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | Germany |
| Tokyo Bay Urayasu Ichikawa Medical Center | Chiba | Japan |
| Kurashiki Central Hospital | Okayama | Japan |
| Omihachiman Community Med Center | Ōmihachiman | Japan |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Akershus University Hospital (AHUS) | Oslo | Norway |
| Hospital Clinic of Barcelona | Barcelona | Spain |
| Hospital Alvaro Cunqueiro | Vigo | Spain |
| University Hospital Basel | Basel | Switzerland |
| Luzerner Kantonsspital | Lucerne | Switzerland |
| NHS Lothian | Edinburgh | United Kingdom |
| Manchester University NHS Foundation Trust | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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