Acute Coronary SyndromePERFORM-TSIXNCT06734117
A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Hoffmann-La Roche at 50 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- Elecsys® Troponin T hs Gen 6 and Blood sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 5,429 participants
- Where
- 50 sitesin 11 countries
- Study dates
- 15 Nov 2021to 26 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 5600 consecutive all-comers with signs and symptoms of acute coronary syndromes presenting to the emergency department.
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- None
Trial locations and contacts
50 sites in 11 countries.
50 sites in 11 countries
United States26 sites
University at Buffalo / Buffalo General Hospital
Buffalo, New York, 14203
University of Buffalo - Erie County Medical Center
Buffalo, New York, 14215
Medical University of South Carolina
Charleston, South Carolina, 29425
Atrium Health
Charlotte, North Carolina, 28203
Dallas VA Medical Center
Dallas, Texas, 75216
Henry Ford Health
Detroit, Michigan, 48202
Duke Regional Hospital
Durham, North Carolina, 27704
Duke University
Durham, North Carolina, 27710
El Centro Regional Medical Center
El Centro, California, 92243
Inova Fairfax Hospital
Falls Church, Virginia, 22042
MUSC Health Florence Medical Center
Florence, South Carolina, 29505
Parkview Research
Fort Wayne, Indiana, 46845
University of Florida
Gainesville, Florida, 32610
Atrium Health Wake Forest Baptist, High Point Medical Center
High Point, North Carolina, 27262
Baylor College of Medicine
Houston, Texas, 77030-2348
University of Kansas Medical Center
Kansas City, Kansas, 66160
UCSD La Jolla ED
La Jolla, California, 92037
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73135-2607
Eastside Research Associates
Redmond, Washington, 98052
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
Tampa General Hospital
Tampa, Florida, 33606
Aspirus Medical Group
Wausau, Wisconsin, 54401-4173
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
China7 sites
Peking University First Hospital
Beijing
Dongguan People's Hospital
Dongguan
Sun Yat-sen Memorial Hospital
Guangzhou
Shanghai Tongren Hospital
Shanghai
TEDA International Cardiovascular Hospital
Tianjin
Tongji Hospital
Wuhan
Zhongnan Hospital of Wuhan University
Wuhan
Germany3 sites
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Universitätsklinikum Heidelberg
Heidelberg
Japan3 sites
Tokyo Bay Urayasu Ichikawa Medical Center
Chiba
Kurashiki Central Hospital
Okayama
Omihachiman Community Med Center
Ōmihachiman
Spain2 sites
Hospital Clinic of Barcelona
Barcelona
Hospital Alvaro Cunqueiro
Vigo
Switzerland2 sites
University Hospital Basel
Basel
Luzerner Kantonsspital
Lucerne
United Kingdom2 sites
NHS Lothian
Edinburgh
Manchester University NHS Foundation Trust
Manchester
About this study
Official title: 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.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Being tested
- Elecsys® Troponin T hs Gen 6, Blood sample collection
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elecsys® Troponin T hs Gen 6Diagnostic 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.
Blood sample collectionProcedure or surgery
Blood will be collected from each recruited individual by a healthcare practitioner at five time points after emergency department presentation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Elecsys® Troponin T hs Gen 6; Procedure: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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
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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: T0fast (0 to 60 minutes) after participant presentation at the emergency department and T1fast (30 to 90 minutes from T0fast sample)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start15 Nov 2021
- Primary completion27 Jun 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Diagnostics GmbH, Roche Diagnostics Operations, Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734117
- Sponsor's protocol ID
- CIM RD005477
- Acronym
- PERFORM-TSIX
- Status last verified
- Jan 2025
- First submitted
- 11 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41553478
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects With Symptoms of Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06734117
- Acronym / sponsor ID
- PERFORM-TSIX / CIM RD005477
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,429 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Roche Diagnostics GmbH, Roche Diagnostics Operations, Inc.
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With Signs and Symptoms of Acute Coronary Syndromes | – | Diagnostic Test: Elecsys® Troponin T hs Gen 6, Procedure: Blood sample collectionThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 5600 consecutive all-comers with signs and symptoms of acute coronary syndromes presenting to the emergency department.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elecsys® Troponin T hs Gen 6It 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. | Diagnostic test | Participants With Signs and Symptoms of Acute Coronary Syndromes |
| Blood sample collectionBlood will be collected from each recruited individual by a healthcare practitioner at five time points after emergency department presentation. | Procedure or surgery | Participants With Signs and Symptoms of Acute Coronary Syndromes |
Primary outcome
Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Timepoint T3aid
Time frame: T3aid (121 to 240 minutes) after participant presentation at the emergency department
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%.
5 secondary outcomes
Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Specified Timepoints
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: T0fast (0 to 60 minutes) after participant presentation at the emergency department and T1fast (30 to 90 minutes from T0fast sample)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 41553478Daniels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
50 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Hoffmann-La Roche at 50 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, China, Germany, Japan, Bulgaria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Elecsys® Troponin T hs Gen 6 Against the Centrally Adjudicated Clinical Diagnosis at Timepoint T3aid (time frame: T3aid (121 to 240 minutes) after participant presentation at the emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06734117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.