Comparison Between High-sensitivity Cardiac Troponin T and Standard Tnl Assays in Early Cardiac Ischemia Detection

Assessment of Highly Sensible T Troponin (Hs-TnT) Assay Compared to Standard Troponin Assay in the Early Detection of Cardiac Ischemia in Patients With Acute Coronary Syndrome

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01374607

Enrollment

Registered

2011-06-16

Start date

2011-07-31

Completion date

2013-12-31

Last updated

2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome, myocardial ischemia, high-sensitivity cardiac troponin T

Brief summary

It is crucial to rapidly identify cardiac ischemia in the care of patients with suspected acute coronary syndrome (ACS). Cardiac troponins are a major factor in the diagnostic of myocardial infarction. New methods have been developed to improve the accuracy of the assay and determine low troponin concentrations. Elecsys® (highly sensible T troponin) TnT-HS assay is supposed to help early detection of myocardial infarction after onset of symptoms. It should therefore shorten the transit time to emergencies by a more rapid intervention or a faster return home. The aim of the study is to compare TnT-HS assay to the standard troponin assay in the detection of early cardiac ischemia in patients with ACS.

Detailed description

Patients with suspected ACS with 2/2 negative results of conventional troponin I assay and 1/3 positive result of highly sensitive troponin assay will have a non invasive cardiac Rb82 PET/CT performed within 24 hours of admission. This exam is recognized by Associations of cardiology for its high sensibility and specificity in coronary disease detection.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* chest pain of ≥ 5 minutes during the last 24 hours, or other symptoms suggestive of ACS (unstable angina or NSTEMI) with 2 negative standard troponin values(\<0.09 µg/L) * age ≥ 18

Exclusion criteria

* patients with ST- segment elevation myocardial infarction (STEMI) * detection of TnI standard values \> 0.09 (limit of positivity) in one of two blood samples (T0 and T6) * detection of heart disease or extra-cardiac disease that could explain the elevated conventional troponin values * presence of major organ dysfunction, infection or major underlying medical condition that could compromise the patient's ability to perform a stress test for myocardial ischemia * cancer with prognosis \< 6 months

Design outcomes

Primary

Measure	Time frame
patients presenting to the emergency for chest pain suspect for ACS currently have 2 troponin assays (Tn I) performed at T0 and T6. The additional value of a high sensitivity cardiac troponin T (Hs-TnT) dosage performed at T0 will be analyzed.	T0 (admission)
patients presenting to the emergency for chest pain suspect for ACS currently have 2 troponin assays (Tn I) performed at T0 and T6. The additional value of a high sensitivity cardiac troponin T (Hs-TnT) dosage performed at T2 will be analyzed.	T2 (2 hours after admission)
patients presenting to the emergency for chest pain suspect for ACS currently have 2 troponin assays (Tn I) performed at T0 and T6. The additional value of a high sensitivity cardiac troponin T (Hs-TnT) dosage performed at T6 will be analyzed.	T6 (6 hours after admission)

Secondary

Measure	Time frame
major cardiovascular events	at 30 days of admission

Countries

Switzerland

Outcome results