PERFORM-TSIX Study V3
Research type
Research Study
Full title
Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects with Symptoms of Acute Coronary Syndrome
IRAS ID
307811
Contact name
Karina Sarney
Contact email
Sponsor organisation
Roche Diagnostics GmbH
Clinicaltrials.gov Identifier
CPMS ID: CARD 51183, NIHR
Duration of Study in the UK
1 years, 4 months, 29 days
Research summary
This multicenter study, conducted at around 42 sites in Europe, the US, China and Japan, will recruit about 5600 subjects with signs and symptoms of acute coronary syndromes (ACS) who present in the emergency department (ED). The data will be used for global regulatory approval of Elecsys® Troponin T hs Gen 6 which is a diagnostic blood test.\n\nThe primary objective is to determine the clinical performance of this new blood test versus the clinical diagnosis at various time points after ED presentation using the previously determined clinical methods. This assay has an improved analytical sensitivity compared to the earlier test, Elecsys® Troponin T hs Biotin PU STAT.\n\nBlood samples will be collected at the time of ED presentation, at 1, 2, 3 hours and optionally at 6hrs after presentation. Results will be used to calculate and validate the use of the test as an aid in the diagnosis of myocardial infarction(MI). Values obtained with the blood test at ED presentation and +1hr will be used to calculate and validate the use of the assay for fast rule-out. To evaluate the prognostic value of the diagnostic test, clinical outcome data will be collected during a 30min telephone call 30 and 180 days later.\n\nCardiac troponins (cTn) in the blood samples will be measured at 4 laboratories with the diagnostic test using different sample materials and various instruments.\n\nThe adjudicated gold standard diagnosis of each patient will be established by a central clinical events committee (CEC) in accordance with the fourth universal definition of MI. Each case will be reviewed by two independent physicians, who have access to all clinical information and the central results (but blinded to results of Elecsys® Troponin T hs Gen 6), and a third physician in case of ties between the first two adjudicators.
Results Summary
The new, highly sensitive blood test, the Elecsys Troponin T hs Gen 6 assay, has been clinically proven in this study to be highly effective in helping doctors diagnose a Myocardial Infarction (MI), or heart attack, in patients who arrive with suspected chest pain.The study confirmed that the test successfully met all necessary acceptance criteria for aiding in the diagnosis of MI according to the latest medical guidelines. A significant finding is the support for a single, global standard for the test's cut-off values (99th percentile URLs), which can be applied consistently across major global regions, regardless of a patient's sex. For this study in total 5,631 subjects had been enroled. 253 subjects were excluded due to various reasons, leaving 5,378 evaluable subjects. 8.66 % of the subjects had a myocardial infarction.
Rapid Diagnosis and Safety
When used with established rapid testing protocols, specifically the ESC 0/1h and 0/2h algorithms, the assay demonstrated robust performance. These protocols allow medical staff to quickly and safely:
Rule out an MI in most patients.
Identify patients who are having an MI and are at high risk, ensuring they receive immediate attention.
This speed and reliability are particularly valuable for patients who seek treatment very soon after their chest pain begins, reinforcing the test's clinical utility for rapid heart attack diagnosis.Prognostic Value
Beyond immediate diagnosis, the results underline the test's important prognostic value. Higher test values indicate an increased likelihood of a future serious event, such as a Major Adverse Cardiac Event (MACE) or all-cause death.
The rapid algorithms are also excellent tools for risk stratification (assessing a patient's risk) over the next 30 to 180 days. Patients categorized in the "rule-in" zone (diagnosed with an MI) showed the highest risk of MACE and death, while those in the "rule-out" zone showed the lowest risk. This confirms that the test not only tells doctors what is happening now but also helps them plan for a patient's future care.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0064
Date of REC Opinion
7 Sep 2022
REC opinion
Further Information Favourable Opinion