Clinical trial NCT06734117: A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome
Official title: Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects With Symptoms of Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Diagnostics GmbH
name: Roche Diagnostics Operations, Inc.
First posted: 2024-12-16
Enrollment: 5429
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 5600 consecutive all-comers with signs and symptoms of acute coronary syndromes presenting to the emergency department.

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 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.


Eligibility criteria: 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:

  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:

* None

Primary outcomes:
measure: Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Timepoint T3aid
timeFrame: T3aid (121 to 240 minutes) after participant presentation at the emergency department
Secondary outcomes:
measure: Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints
timeFrame: 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
measure: Specificity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints
timeFrame: 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
measure: Negative Predictive Value of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints
timeFrame: 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
measure: Positive Predictive Value of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints
timeFrame: 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
measure: 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
timeFrame: T0fast (0 to 60 minutes) after participant presentation at the emergency department and T1fast (30 to 90 minutes from T0fast sample)
Other outcomes:
Locations:
city: El Centro
country: United States
facility: El Centro Regional Medical Center
state: California
city: La Jolla
country: United States
facility: UCSD La Jolla ED
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Fort Wayne
country: United States
facility: Parkview Research
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Buffalo
country: United States
facility: University at Buffalo / Buffalo General Hospital
state: New York
city: Buffalo
country: United States
facility: University of Buffalo - Erie County Medical Center
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Durham
country: United States
facility: Duke Regional Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: High Point
country: United States
facility: Atrium Health Wake Forest Baptist, High Point Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Florence
country: United States
facility: MUSC Health Florence Medical Center
state: South Carolina
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Wausau
country: United States
facility: Aspirus Medical Group
state: Wisconsin
city: Vienna
country: Austria
facility: Medical University Vienna
city: Burgas
country: Bulgaria
facility: MHAT "Heart and Brain"
city: Pleven
country: Bulgaria
facility: MHAT "Heart and Brain"
city: Beijing
country: China
facility: Peking University First Hospital
city: Dongguan
country: China
facility: Dongguan People's Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
city: Wuhan
country: China
facility: Tongji Hospital
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Chiba
country: Japan
facility: Tokyo Bay Urayasu Ichikawa Medical Center
city: Okayama
country: Japan
facility: Kurashiki Central Hospital
city: Omihachiman-Shi
country: Japan
facility: Omihachiman Community Med Center
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Oslo
country: Norway
facility: Akershus University Hospital (AHUS)
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: