NCT06734117Completed
A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome
Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects With Symptoms of Acute Coronary Syndrome
Source: ClinicalTrials.gov · Last updated 24 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 5429 (actual)
- First submitted
- 11 Dec 2024
- Start date
- 15 Nov 2021
- Primary completion date
- 27 Jun 2024
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Coronary artery disease
- NCT number
- NCT06734117
What you commit to
- Study type: Observational
- Participants enrolled: 5429
- From 15 Nov 2021 to the primary completion date, 27 Jun 2024
- 50 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| MHAT Heart and brain Coordinator of this site? Confirm its status | Burgas | Bulgaria | Unknown status |
| MHAT Heart and brain Coordinator of this site? Confirm its status | Pleven | Bulgaria | Unknown status |
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Luzerner Kantonsspital Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Unknown status |
| Sun Yat-sen Memorial Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shanghai Tongren Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| TEDA International Cardiovascular Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitätsklinikum Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Universitätsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Hospital Clinic of Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| NHS Lothian Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Tokyo Bay Urayasu Ichikawa Medical Center Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Kurashiki Central Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Omihachiman Community Med Center Coordinator of this site? Confirm its status | Ōmihachiman | Japan | Unknown status |
| Catharina Ziekenhuis Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| Akershus University Hospital (AHUS) Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| University at Buffalo / Buffalo General Hospital Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Buffalo - Erie County Medical Center Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Atrium Health Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Dallas VA Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Henry Ford Health Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Duke Regional Hospital Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| El Centro Regional Medical Center Coordinator of this site? Confirm its status | El Centro | United States | Unknown status |
| Inova Fairfax Hospital Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| MUSC Health Florence Medical Center Coordinator of this site? Confirm its status | Florence | United States | Unknown status |
| Parkview Research Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Atrium Health Wake Forest Baptist, High Point Medical Center Coordinator of this site? Confirm its status | High Point | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| UCSD La Jolla ED Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Minneapolis Heart Institute Foundation Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Long Island Jewish Medical Center Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Sentara Norfolk General Hospital Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Oklahoma Heart Hospital Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Eastside Research Associates Coordinator of this site? Confirm its status | Redmond | United States | Unknown status |
| MultiCare Institute for Research & Innovation Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Aspirus Medical Group Coordinator of this site? Confirm its status | Wausau | United States | Unknown status |
| Wake Forest Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
Related publications
- 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 · PMID 41553478
This page is information, not medical advice. Discuss any trial with your doctor.