A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome (PERFORM-TSIX)

Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects With Symptoms of Acute Coronary Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Acute Coronary Syndrome
• Intervention / Treatment: Diagnostic test: Elecsys® Troponin T hs Gen 6; Procedure: Blood sample collection

• Study Type: Observational
• Enrollment (Actual): 5429

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University Vienna
• Bulgaria
  • Burgas, Bulgaria
    • MHAT "Heart and Brain"
  • Pleven, Bulgaria
    • MHAT "Heart and Brain"
• China
  • Beijing, China
    • Peking University First Hospital
  • Dongguan, China
    • Dongguan People's Hospital
  • Guangzhou, China
    • Sun Yat-Sen Memorial Hospital
  • Shanghai, China
    • Shanghai Tongren Hospital
  • Tianjin, China
    • Teda International Cardiovascular Hospital
  • Wuhan, China
    • Zhongnan Hospital of Wuhan University
  • Wuhan, China
    • Tongji Hospital
• Germany
  • Berlin, Germany
    • Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg
• Japan
  • Chiba, Japan
    • Tokyo Bay Urayasu Ichikawa Medical Center
  • Okayama, Japan
    • Kurashiki Central Hospital
  • Omihachiman-Shi, Japan
    • Omihachiman Community Med Center
• Netherlands
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis
• Norway
  • Oslo, Norway
    • Akershus University Hospital (Ahus)
• Spain
  • Barcelona, Spain
    • Hospital Clinic of Barcelona
  • Vigo, Spain
    • Hospital Álvaro Cunqueiro
• Switzerland
  • Basel, Switzerland
    • University Hospital Basel
  • Luzern, Switzerland
    • Luzerner Kantonsspital
• United Kingdom
  • Edinburgh, United Kingdom
    • NHS Lothian
  • Manchester, United Kingdom
    • Manchester University NHS Foundation Trust
• United States
  • California
    • El Centro, California, United States, 92243
      • El Centro Regional Medical Center
    • La Jolla, California, United States, 92037
      • UCSD La Jolla ED
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • New York
    • Buffalo, New York, United States, 14215
      • University of Buffalo - Erie County Medical Center
    • Buffalo, New York, United States, 14203
      • University at Buffalo / Buffalo General Hospital
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Durham, North Carolina, United States, 27704
      • Duke Regional Hospital
    • High Point, North Carolina, United States, 27262
      • Atrium Health Wake Forest Baptist, High Point Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135-2607
      • Oklahoma Heart Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Florence, South Carolina, United States, 29505
      • MUSC Health Florence Medical Center
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
    • Houston, Texas, United States, 77030-2348
      • Baylor College of Medicine
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Redmond, Washington, United States, 98052
      • Eastside Research Associates
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research & Innovation
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401-4173
      • Aspirus Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints	The sensitivity of a diagnostic test is the percentage of true positive tests out of all patients with a condition. It is calculated as follows: (TP)/(TP + FN)*100%.	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	The specificity of a diagnostic test is the percentage of true negative (TN) tests out of all patients who do not have a condition. It is calculated as follows: (TN)/(TN + false positives (FP))*100%.	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	The negative predictive value of a diagnostic test is the percentage of true negative tests out of all of the negative findings. It is calculated as follows: (TN)/(TN + FN)*100%.	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	The positive predictive value of a diagnostic test is the percentage of true positive tests out of all of the positive findings. It is calculated as follows: (TP)/(TP + FP)*100%.	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	The negative predictive value of a diagnostic test is the percentage of true negative tests out of all of the negative findings. It is calculated as follows: (TN)/(TN + FN)*100%.	T0fast (0 to 60 minutes) after participant presentation at the emergency department and T1fast (30 to 90 minutes from T0fast sample)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Roche Diagnostics GmbH; Roche Diagnostics Operations, Inc.
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): June 27, 2024
• Study Completion (Actual): December 26, 2024

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Necrosis; Myocardial Ischemia; Ischemia; Syndrome; Myocardial Infarction; Infarction; Acute Coronary Syndrome
• Other Study ID Numbers: CIM RD005477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No