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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
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

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medical University Vienna
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ViennaAustriaUnknown status
MHAT Heart and brain
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BurgasBulgariaUnknown status
MHAT Heart and brain
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PlevenBulgariaUnknown status
University Hospital Basel
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BaselSwitzerlandUnknown status
Luzerner Kantonsspital
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LucerneSwitzerlandUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Dongguan People's Hospital
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DongguanChinaUnknown status
Sun Yat-sen Memorial Hospital
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GuangzhouChinaUnknown status
Shanghai Tongren Hospital
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ShanghaiChinaUnknown status
TEDA International Cardiovascular Hospital
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TianjinChinaUnknown status
Tongji Hospital
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WuhanChinaUnknown status
Zhongnan Hospital of Wuhan University
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WuhanChinaUnknown status
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
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BerlinGermanyUnknown status
Universitätsklinikum Hamburg-Eppendorf
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HamburgGermanyUnknown status
Universitätsklinikum Heidelberg
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HeidelbergGermanyUnknown status
Hospital Clinic of Barcelona
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BarcelonaSpainUnknown status
Hospital Alvaro Cunqueiro
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VigoSpainUnknown status
NHS Lothian
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EdinburghUnited KingdomUnknown status
Manchester University NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
Tokyo Bay Urayasu Ichikawa Medical Center
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ChibaJapanUnknown status
Kurashiki Central Hospital
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OkayamaJapanUnknown status
Omihachiman Community Med Center
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ŌmihachimanJapanUnknown status
Catharina Ziekenhuis
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EindhovenNetherlandsUnknown status
Akershus University Hospital (AHUS)
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OsloNorwayUnknown status
University at Buffalo / Buffalo General Hospital
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BuffaloUnited StatesUnknown status
University of Buffalo - Erie County Medical Center
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BuffaloUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Atrium Health
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CharlotteUnited StatesUnknown status
Dallas VA Medical Center
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DallasUnited StatesUnknown status
Henry Ford Health
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DetroitUnited StatesUnknown status
Duke University
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DurhamUnited StatesUnknown status
Duke Regional Hospital
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DurhamUnited StatesUnknown status
El Centro Regional Medical Center
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El CentroUnited StatesUnknown status
Inova Fairfax Hospital
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Falls ChurchUnited StatesUnknown status
MUSC Health Florence Medical Center
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FlorenceUnited StatesUnknown status
Parkview Research
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Fort WayneUnited StatesUnknown status
University of Florida
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GainesvilleUnited StatesUnknown status
Atrium Health Wake Forest Baptist, High Point Medical Center
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High PointUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
UCSD La Jolla ED
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La JollaUnited StatesUnknown status
Minneapolis Heart Institute Foundation
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MinneapolisUnited StatesUnknown status
Long Island Jewish Medical Center
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New Hyde ParkUnited StatesUnknown status
Sentara Norfolk General Hospital
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NorfolkUnited StatesUnknown status
Oklahoma Heart Hospital
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Oklahoma CityUnited StatesUnknown status
Eastside Research Associates
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RedmondUnited StatesUnknown status
MultiCare Institute for Research & Innovation
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TacomaUnited StatesUnknown status
Tampa General Hospital
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TampaUnited StatesUnknown status
Aspirus Medical Group
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WausauUnited StatesUnknown status
Wake Forest Health Sciences
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Winston-SalemUnited StatesUnknown status

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