Novel prognostic biomarker in acute myocardial infarction

Abstract

A diagnostic method for determining prognosis of a myocardial infarcted patient, wherein the amounts of FXIII protein are determined on the day of myocardial infarction (t0) and at least on the following three days (t1 to t3), wherein a lowering of FXIII amount on any one of t0 to t3 below a threshold value is indicative of an increased risk of poor prognosis.

1 . Diagnostic kit for determining FXIII protein levels in biological samples of a myocardial infarcted patient, the kit comprising:
 means for detecting the amount of FXIII protein in the biological samples, and   at least four sample collecting tubes suitable to collect the at least four patient biological samples taken on the day of myocardial infarction (t0) and at least on the following three days (t1 to t3).   
     
     
         2 . Diagnostic kit according to  claim 1 , wherein the kit comprises at least two further sample collecting tubes suitable to collect at least two further patient biological samples taken on at least the fourth and fifth day following myocardial infarction (t4 to t5). 
     
     
         3 . Diagnostic kit according to  claim 1 , wherein the sample collecting tubes contain each at least one anti-proteolytic agent and an anti-coagulating agent. 
     
     
         4 . Diagnostic kit according to  claim 3 , wherein the at least one anti-proteolytic agent is selected among aprotinin, heparin, antithrombin, hirudin, EDTA (Ethylenediaminetetraacetic acid), EGTA (Ethylene glycol-bis(β-aminoethyl ether)tetraacetic acid), Leupeptin, iodoacetamide, APMSF ((4-Amidino-phenyl)methane-sulfonyl fluoride), 4-(2-Aminoethyl)-benzenesulfonyl-flouride hydrochloride, a2-Macroglobulin. 
     
     
         5 . Diagnostic kit according to  claim 1 , wherein the means for detecting the amount of FXIII protein comprises a specific binding ligand of FXIII protein, the specific binding ligand of FXIII protein being preferably coated onto a solid phase. 
     
     
         6 . Diagnostic kit according to  claim 5 , wherein the specific binding ligand is selected between anti-FXIII polyclonal and monoclonal antibody. 
     
     
         7 . Diagnostic kit according to  claim 1 , wherein the kit comprises at least one normal control, wherein the normal control comprises a fixed amount of FXIII protein. 
     
     
         8 . Method for predicting prognosis of a myocardial infarcted patient, the method comprising:
 providing at least four biological samples of the infarcted patient, the at least four samples being collected on the day of myocardial infarction (t0) and at least on the following three days (t1 to t3);   determining the amounts of FXIII protein in each biological sample;   wherein a lowering of FXIII protein amount in any one of t0 to t3 biological samples below a threshold value is indicative of a poor prognosis.   
     
     
         9 . Method according to  claim 8 , wherein the method further comprises:
 providing at least two further biological samples of the infarcted patient, the at least two further samples being collected on at least the fourth and fifth day following myocardial infarction (t4 to t5);   determining the amounts of FXIII protein in t4 and t5 biological sample;   wherein a lowering of FXIII protein amount in any one of t4 and t5 biological samples below a threshold value is indicative of a poor prognosis.   
     
     
         10 . Method according to  claim 8 , wherein the threshold value of FXIII protein amount is evaluated as a percentage of the FXIII amount of a positive control. 
     
     
         11 . Method according to  claim 8 , wherein the threshold value of FXIII protein amount for each t0 to t5 biological sample is expressed as percentage of FXIII protein amount of a normal control, such amount being fixed to 100%, wherein the threshold values are: 
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Threshold 
                 
                     
                   sample 
                   (FXIII %) 
                 
                     
                     
                 
                     
                   t0 
                   88.0 
                 
                     
                   t1 
                   87.7 
                 
                     
                   t2 
                   85.8 
                 
                     
                   t3 
                   75.6 
                 
                     
                   t4 
                   74.9 
                 
                     
                   t5 
                   63.0 
                 
                     
                     
                 
             
                
                
                
                
               
               
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         12 . Method according to  claim 8 , wherein the patient biological samples are collected in sample collecting tubes containing at least one anti-proteolytic agent and an anti-coagulating agent. 
     
     
         13 . Method according to  claim 8 , wherein the patient biological samples are whole blood, plasma or serum samples.