Means and methods for recognizing the development of cardiovascular disease in an individual

Abstract

A method of recognizing the development of an Acute Myocardial Infarction (AMI) process in an individual, wherein the method comprises steps of: profiling specific antibody reactivities or biomarkers associated with AMI susceptibility, the profiling comprises steps of: attaching a set of defined antigens to a substrate; obtaining a biological fluid derived specimen from an individual, the specimen containing a specific antibody repertoire; and binding said antibodies of the biological fluid specimen to the attached antigens thereby forming bound antibody antigen complexes; and analyzing results obtained, wherein the presence of the complexes is indicative of AMI.

1 - 86 . (canceled) 
     
     
         87 . A method of recognizing the development of an Acute Myocardial Infarction (AMI) process in an individual, wherein said method comprises steps of:
 a. profiling specific antibody reactivities or biomarkers associated with AMI susceptibility, said profiling comprises steps of:
 i. attaching a set of defined antigens to a substrate; 
 ii. obtaining a biological fluid derived specimen from an individual, said specimen containing a specific antibody repertoire; and, 
 iii. binding said antibodies of said biological fluid specimen to said attached antigens thereby forming bound antibody antigen complexes; and, 
 iv. analysing results obtained, wherein the presence of said complexes is indicative of AMI. 
   
     
     
         88 . The method according to  claim 87 , wherein said profiling further comprises the steps of obtaining said defined antigens characterized by association with a variety of conditions selected from a group consisting of inflammation, angiogenesis, apoptosis or any other condition involving immune regulation or any combination thereof further wherein said profiling further comprises the steps of selecting said biological fluid derived specimen from a group consisting of plasma, serum, blood, cerebrospinal fluid, synovial fluid, sputum, saliva, tears, lymph specimen, or any other biological fluid known in the art. 
     
     
         89 . The method according to  claim 87 , wherein said profiling further comprises steps of selecting said substrate from a group consisting of microarray chip, microarray wafers, microarray strips, ELISA microwells, multiplex beads or any substrate known in the relevant art, said method further comprising steps of selecting said antigens from a group consisting of protein, polypeptide, peptide, nucleic acids, lipids, glycosylated molecules, polypeptides with modifications, polysaccharides or any other biological molecule known in the art. 
     
     
         90 . The method according to  claim 87 , further comprises the steps of defining said antibody reactivities as IgG, IgM, IgA, IgE antibody isotypes or more specific sub-isotypes of said antibodies. 
     
     
         91 . The method according to  claim 87 , wherein said analyzing results obtained further comprises the steps of measuring said bound antibody complexes further wherein said measuring additionally comprises steps of labeling said bound antibody complexes, said labeling further comprises the steps of selecting a labeling signal from a group consisting of fluorescent, chemiluminescent, absorptive, electronic, radioactive, paramagnetic or any labeling signal known in the art, or combination thereof and wherein said labeling step additionally comprises steps of reacting said bound antibody complexes with labeled mixture of secondary antibodies specific for human immunoglobulin types so as to obtain labeled bound antibody antigen complexes. 
     
     
         92 . The method according to  claim 87 , wherein said analyzing step additionally comprises steps of:
 a. scanning the signal produced by said bound antibody complexes so as to form a reactivity matrix;   b. measuring the intensity of said signal;   c. generating and recording results of data associated with said intensity of said signal;   d. producing said results in the form of a signature, profile, set, pattern or matrix characteristic to said individual;   e. comparing said results with a databank containing data concerning said antibody reactivities in populations susceptible to AMI thereby identifying the development of an Acute Myocardial Infarction (AMI) process in said individual further wherein said measuring and scanning steps are selected from a group consisting of Surface Plasmon Resonance (SPR), ellipsometry, laser scanning, light detecting, photon detecting via a photon multiplier, photographing with a digital camera based system or video system, radiation counting, fluorescence detecting, electronic, magnetic detecting or any other technique known in the art or combination thereof.   
     
     
         93 . The method according to  claim 87 , wherein said analyzing step further comprises the steps of defining said reactivity as a relative intensity signal of a specific bound antibody as compared to its intensity signal in healthy control individuals. 
     
     
         94 . The method according to  claim 87 , wherein said analyzing step further comprises the steps of defining said reactivity as a relative intensity signal of a specific bound antibody as compared to its intensity signal in individuals who have had a stroke event. 
     
     
         95 . The method according to  claim 87 , wherein said analyzing step further comprises the steps of identifying a set of informative antigens possessing higher or a lower intensity reactivity matrix signals as compared to said intensity signals of said antibodies in healthy control individuals or wherein said analyzing step further comprises the steps of identifying a set of informative antigens possessing higher or a lower intensity reactivity matrix signals as compared to said intensity signals of said antibodies in individuals who have had a stroke event. 
     
     
         96 . The method according to  claim 87  wherein said method is adapted to recognize the development of a stroke process in an individual, further wherein said method comprises steps of:
 a. profiling specific antibody reactivities or biomarkers associated with stroke susceptibility, said profiling comprises steps of :
 i. attaching a set of defined antigens to a substrate; 
 ii. obtaining a biological fluid derived specimen from an individual, said specimen containing a specific antibody repertoire; and, 
 iii. binding said antibodies of said biological fluid specimen to said attached antigens thereby forming bound antibody antigen complexes; and, 
 
 b. analysing results obtained, wherein the presence of said complexes is indicative of the development of a stroke process in an individual. 
 
     
     
         97 . A set of informative antigens useful for recognizing the development of an Acute Myocardial Infarction (AMI) process in an individual said set of antigens selected from a group consisting of Brain-1 oligo-dendrocyte transcription factor, Synaptotagmin 1, Tryptophan hydroxylase peptide 1, Tryptophan hydroxylase peptide 2, BSP (Brain specific protein), myelin associated glycoprotein, Fibronectin, Caspase 3, Myelin-associated metalloproteinase, CD68, Bone morphogenic protein 4 and D4GDI (GDP-dissociation inhibitor), said informative antigens are identified by:
 a. profiling means for profiling specific antibody reactivities or biomarkers associated with AMI susceptibility, said profiling means further comprises:
 i. attaching means for attaching a set of defined antigens to a substrate; 
 ii. a biological fluid derived specimen from an individual, said specimen containing a specific antibody repertoire; and, 
 iii. binding means for binding said antibodies of said biological fluid specimen to said attached antigens thereby forming bound antibody antigen complexes; and, 
   b. analyzing means for analyzing results obtained.   
       wherein said antigens are further characterised by their specific antibody reactivity with human antibodies associated with susceptibility to AMI. 
     
     
         98 . The set of informative antigens according to  claim 97 , wherein said defined antigens characterized by association with a variety of conditions selected from a group consisting of inflammation, angiogenesis, apoptosis or any other condition involving immune regulation or any combination thereof. 
     
     
         99 . The set of informative antigens according to  claim 97 , wherein at least one of the following is true; said defined antigens are attached to a substrate selected from a group consisting of microarray chip, microarray wafers, microarray strips, ELISA microwells, multiplex beads or any substrate known in the relevant art; said defined antigens are selected form a group consisting of protein, polypeptide, peptide, nucleic acids, lipids, glycosylated molecules, polypeptides with modifications, polysaccharides or any other biological molecule known in the art. 
     
     
         100 . The set of informative antigens according to  claim 97 , wherein said antigens are further characterized by their specific capability to discriminate between the development of an AMI process in an individual and a healthy control individual or wherein said set of informative antigens are further characterized by their specific capability to discriminate between the development of an AMI process and a stroke process in an individual. 
     
     
         101 . The set of informative antigens according to  claim 97 , wherein at least one of the following is true; said human antibodies are derived from a biological fluid specimen selected from a group consisting of plasma, serum, blood, cerebrospinal fluid, synovial fluid, sputum, saliva, tears, lymph specimen, or any biological fluid known in the art; said set of informative antigens have said antibody reactivities defined as IgG, IgM, IgA, IgE antibody isotypes or more specific sub-isotypes of said antibodies further wherein said specific antibody reactivity is analyzable by using measuring means; said set of informative antigens have said specific antibody reactivity is analyzable by using labeling means further wherein said labeling means comprises labeling signal selected form a group consisting of fluorescent, chemiluminescent, absorptive, electronic, radioactive, paramagnetic or any labeling signal known in the art, or combination thereof. 
     
     
         102 . The set of informative antigens according to  claim 101 , wherein said labeling means is adapted to label said human antibodies with a mixture of secondary antibodies specific for human immunoglobulin types to form a reactivity matrix. 
     
     
         103 . The set of informative antigens according to  claim 97 , wherein said specific antibody reactivity is further analyzable by:
 a. using a scanning means for scanning said reactivity matrix signal;   b. using a measuring means for measuring said intensity of said signal;   c. using generating and recording means for generating and recording results associated with said reactivity matrix signal;   d. using producing means for producing said results in the form of a signature, profile, set, pattern or matrix characteristic to said individual; and,   e. using means for comparing said results with a databank containing data concerning said antibody reactivities in populations susceptible to AMI, thereby identifying the development of an Acute Myocardial Infarction (AMI) process in said individual further wherein said measuring and scanning means are selected from a group consisting of Surface Plasmon Resonance (SPR), ellipsometry, laser scanning, light detecting, photon detecting via a photon multiplier, photographing with a digital camera based system or video system, radiation counting, fluorescence detecting, electronic, magnetic detecting or any other technique known in the art or combination thereof.   
     
     
         104 . The set of informative antigens according to  claim 97 , wherein said reactivity is defined as a relative intensity of a specific antibody bound antigen as compared to its intensity signal in healthy control individuals or wherein said reactivity is defined as a relative intensity of a specific antibody bound antigen as compared to its intensity signal individuals who have had a stroke event. 
     
     
         105 . The set of informative antigens according to  claim 97 , wherein said reactivity is further defined as a set of informative antigens possessing a higher or a lower intensity reactivity signals as compared to said intensity signals of said antigens in said healthy control individuals or wherein said reactivity is further defined as a set of informative antigens possessing a higher or a lower intensity reactivity signals as compared to said intensity signals of said antigens in individuals who have had a stroke event or wherein said set of antigens are useful as therapeutic agents or vaccines against the inflammatory process in AMI and stroke conditions in an individual. 
     
     
         106 . A kit useful for recognizing the development of an Acute Myocardial Infarction (AMI) process in an individual, said kit comprising:
 a. a set of antigens selected from a group consisting of Brain-1 oligo-dendrocyte transcription factor, Synaptotagmin 1, Tryptophan hydroxylase peptide 1, Tryptophan hydroxylase peptide 2, BSP (Brain specific protein), myelin associated glycoprotein, Fibronectin, Caspase 3, Myelin-associated metalloproteinase, CD68, Bone morphogenic protein 4 and D4GDI (GDP-dissociation inhibitor) attached to a substrate, wherein said antigens are further characterised by their specific ability to form bound antibody antigen reactivity complexes with human specimen containing antibodies associated with susceptibility to AMI;   b. a mixture of secondary labeled antibodies specific for human immunoglobulin types;   c. components or solutions useful for reacting said antigens with said antibodies of said specimen;   d. components or solutions useful for reacting said antigen antibody complexes with said secondary labeled antibodies; and,   e. instructions for reacting said antigens with said components and said complexes with said secondary antibodies in vitro so as to obtain results useful for identifying an Acute Myocardial Infarction (AMI) process in an individual.