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TnT BASED DIAGNOSIS OF PAROXYSMAL ATRIAL FIBRILLATION

a paroxysmal atrial fibrillation and diagnosis technology, applied in the field of paroxysmal atrial fibrillation diagnosis based on tnt, can solve the problems of difficult diagnosis difficult recognition of paroxysmal atrial fibrillation, and difficulty in recognizing paroxysmal atrial fibrillation

Inactive Publication Date: 2015-08-20
ROCHE DIAGNOSTICS OPERATIONS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention relates to a method for diagnosing a recent paroxysmal atrial fibrillation by measuring certain markers such as cardiac Troponin, NT-proBNP, hsCRP, IL-6, and IGFBP7 in a sample from the subject and comparing them to a reference amount. The invention also includes a method for identifying a subject who may benefit from anticoagulation therapy and diagnosing an ongoing atrial fibrillation by measuring the amount of IGFBP7. The patent also includes systems, reagents, and kits for use in performing the methods.

Problems solved by technology

However, atrial fibrillation (AF) is frequently no recognized by the patient.
While these numbers relate to persistent atrial fibrillation, paroxysmal atrial fibrillation is even more difficult to diagnose and can only be captured by inpatient cardiac telemetry or even Holter Monitoring.
Thus recognition of paroxysmal atrial fibrillation is a significant challenge, specifically as at least 1% of the general population has persistent atrial fibrillation and the frequency increases with age (Rizos T. et al).
Untreated patients have an increased stroke risk (w / o anticoagulation).
However, Holter Monitoring can only detect atrial fibrillation if the arrhythmia occurs in the 24 hour period of ECG recording.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Patient Cohort

[0234]TnT-hs, IL-6, NT-proBNP, and hsCRP levels have been determined in plasma samples of n=46 patients with blood sampled and biomarkers assayed, in sinus rhythm (SR) at 12-month visit. All patients have >=1 recurrence of Atrial fibrillation from randomization to 12-month visit. All 46 patients spontaneously converted to sinus rhythm.[0235]0-7 days after paroxysmal Atrial fibrillation (AF); n=9 patients[0236]8-30 days after paroxysmal AF; n=10 patients

example 2

Assays

[0237]Troponin T was determined using Roche's electrochemiluminescence ELISA sandwich test Elecsys Troponin T hs (high sensitive) STAT (Short Turn Around Time) assay. The test employs two monoclonal antibodies specifically directed against human cardiac troponin T. The antibodies recognize two epitopes (amino acid position 125-131 and 136-147) located in the central part of the cardiac troponin T protein, which consists of 288 amino acids. The hs-TnT assay allows a measurement of troponin T levels in the range of 3 to 10000 pg / mL.

[0238]NT-proBNP was determined using Roche's electrochemiluminescence ELISA sandwich test Elecsys proBNP II STAT (Short Turn Around Time) assay. The test employs two monoclonal antibodies which recognize epitopes located in the N-terminal part (1-76) of proBNP (1-108).

[0239]IL-6 (Interleukin 6) was measured by an electrochemiluminescent immunoassay (ECLIA, Roche Diagnostics). The test was performed using a Cobas E601 analyzer from Roche Diagnostics. T...

example 3

Results

[0241]The results are shown in the following table.

days afterparoxy- smalatrial hsTnTNt-hsCRPIL-6fibrillation(pg / mL)proBNPmg / lpg / ml0-7 (n =6) 8.371914.202.218-30 (n =10)6.51584.352.04

[0242]Data evaluation showed that patients with TnT-hs levels (independent from other biomarker) above a reference value (in the study >6 pg / mL) are suspected to have paroxysmal Atrial fibrillation and may benefit from anticoagulation. It is even shown, that TnT-hs levels may be detected in patients presenting 7-30 days later in sinus rhythm. Other markers such as hsCRP show a slightly different kinetic after spontaneous termination of atrial fibrillation and may thus individually and / or in combination assist in the detection of past episodes of paroxysmal atrial fibrillation.

[0243]Thus, the diagnosis of recent occurrence of paroxysmal Atrial Fibrillation in patients presenting within 7-30 days later in sinus rhythm may be achieved with detection of enhanced levels of Troponin T alone or in combi...

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Abstract

The present invention relates to a method for diagnosing a recent paroxysmal atrial fibrillation. The method is based on the determination of the at least one marker selected from the group consisting of a cardiac Troponin, NT-proBNP (N-terminal prohormone of brain natriuretic peptide), hsCRP, IL-6 (Interleukin-6) and IGFBP7 (Insulin like growth factor binding protein 7) in a sample from the subject, and on the comparison of the, thus, determined amount(s) with a reference amount (reference amounts). Further, the present invention relates to a method for identifying a subject being treatable with anticoagulation therapy. Further envisaged are systems, reagents and kits used in performing the methods disclosed herein.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of International Application No. PCT / EP2013 / 073476 filed Nov. 11, 2013, which claims priority to Application No. EP 12191996.3 filed Nov. 9, 2012, the disclosures of which are hereby incorporated by reference in their entirety.BACKGROUND OF THE INVENTION[0002]Atrial fibrillation is the most common cardiac arrhythmia. However, atrial fibrillation (AF) is frequently no recognized by the patient. This is the case in approximately 40% of patients indicating that history taking in insensitive for the diagnosis of atrial fibrillation (Kamel H. et al, Curr Atheroscler Rep 2011: 13: 338-343). While these numbers relate to persistent atrial fibrillation, paroxysmal atrial fibrillation is even more difficult to diagnose and can only be captured by inpatient cardiac telemetry or even Holter Monitoring. Thus recognition of paroxysmal atrial fibrillation is a significant challenge, specifically as at least 1% of the ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G01N33/68
CPCG01N33/68G01N33/6887G01N2333/4737G01N2333/5412G01N2333/58G01N33/6893G01N33/74G01N33/6869G01N2333/4712G01N2333/4745G01N2800/326G01N2800/52
Inventor BLOCK, DIRKLATINI, ROBERTOMASSON, SERGEWIENHUES-THELEN, URSULA-HENRIKEZAUGG, CHRISTIANZIEGLER, ANDRE
Owner ROCHE DIAGNOSTICS OPERATIONS INC
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