A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome

NCT06734117 | Completed

• 1 other identifier: CIM RD005477
• Study Type: observational
• Target: 5,429
• Locations: 11 countries
• Sites: 50

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints

  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

• Specificity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints

  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

  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

  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

  T0fast (0 to 60 minutes) after participant presentation at the emergency department and T1fast (30 to 90 minutes from T0fast sample)

Study Arms (1)

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.

Diagnostic Test: Elecsys® Troponin T hs Gen 6; Procedure: Blood sample collection

Interventions

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.

Participants With Signs and Symptoms of Acute Coronary Syndromes

Blood sample collection PROCEDURE

Blood will be collected from each recruited individual by a healthcare practitioner at five time points after emergency department presentation.

Participants With Signs and Symptoms of Acute Coronary Syndromes

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Approximately 5600 consecutive all-comers with signs and symptoms of acute coronary syndromes presenting to the emergency department.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Roche Diagnostics GmbH: collaborator
• Roche Diagnostics Operations, Inc.: collaborator

Study Sites (50)

El Centro Regional Medical Center

El Centro, California, 92243, United States

Location

UCSD La Jolla ED

La Jolla, California, 92037, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Parkview Research

Fort Wayne, Indiana, 46845, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

University at Buffalo / Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

University of Buffalo - Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Duke Regional Hospital

Durham, North Carolina, 27704, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Atrium Health Wake Forest Baptist, High Point Medical Center

High Point, North Carolina, 27262, United States

Location

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73135-2607, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MUSC Health Florence Medical Center

Florence, South Carolina, 29505, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Baylor College of Medicine

Houston, Texas, 77030-2348, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Eastside Research Associates

Redmond, Washington, 98052, United States

Location

MultiCare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

Location

Aspirus Medical Group

Wausau, Wisconsin, 54401-4173, United States

Location

Medical University Vienna

Vienna, Austria

Location

MHAT "Heart and Brain"

Burgas, Bulgaria

Location

MHAT "Heart and Brain"

Pleven, Bulgaria

Location

Peking University First Hospital

Beijing, China

Location

Dongguan People's Hospital

Dongguan, China

Location

Sun Yat-sen Memorial Hospital

Guangzhou, China

Location

Shanghai Tongren Hospital

Shanghai, China

Location

TEDA International Cardiovascular Hospital

Tianjin, China

Location

Tongji Hospital

Wuhan, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, China

Location

Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

Berlin, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Tokyo Bay Urayasu Ichikawa Medical Center

Chiba, Japan

Location

Kurashiki Central Hospital

Okayama, Japan

Location

Omihachiman Community Med Center

Ōmihachiman, Japan

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Akershus University Hospital (AHUS)

Oslo, Norway

Location

Hospital Clinic of Barcelona

Barcelona, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Spain

Location

University Hospital Basel

Basel, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

NHS Lothian

Edinburgh, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41553478 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: November 15, 2021
• Primary Completion: June 27, 2024
• Study Completion: December 26, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); BU (2); GB (2); JP (3); ES (2); CN (7); AU (1); NL (1); NO (1); US (26); DE (3)