A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome
NCT ID: NCT06734117
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5429 participants
OBSERVATIONAL
2021-11-15
2024-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Elecsys® Troponin T hs Gen 6
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.
Blood sample collection
Blood will be collected from each recruited individual by a healthcare practitioner at five time points after emergency department presentation.
Interventions
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Elecsys® Troponin T hs Gen 6
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.
Blood sample collection
Blood will be collected from each recruited individual by a healthcare practitioner at five time points after emergency department presentation.
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Chest pain, pressure, or a burning sensation across the precordium and epigastrium;
2. Pain that radiates to neck, shoulder, jaw, back, upper abdomen, or either arm;
3. Acute onset or worsening dyspnea;
4. Nausea, vomiting or indigestion;
5. Lightheadedness or syncope;
6. Diaphoresis;
7. Generalized weakness or fatigue; OR, asymptomatic subjects or patients with atypical symptoms in whom myocardial infarction is being suspected.
Exclusion Criteria
20 Years
ALL
No
Sponsors
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Roche Diagnostics GmbH
INDUSTRY
Roche Diagnostics Operations, Inc.
UNKNOWN
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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"
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
Countries
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Other Identifiers
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CIM RD005477
Identifier Type: -
Identifier Source: org_study_id
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