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Resumen

The present invention relates to PIGR, APOA, HPT, HEP2, C5, ITIH1 and IGHA2 as biomarkers for the screening, diagnosis and/or monitoring of subclinical atherosclerosis and methods and kits using thereof.

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1. A method for the screening, diagnosis and/or monitoring of subclinical atherosclerosis, preferably generalized subclinical atherosclerosis, in a subject, wherein said method comprises: a) determining in a biological sample isolated from said subject the protein expression levels of: i. PIGR and/or IGHA2; and ii. optionally, one, two, three, four or five biomarkers, selected from APOA, HPT, HEP2, ITIH1 and C5; b) comparing the levels of the biomarkers with a reference value; c) wherein when the levels in the subject's sample of PIGR and/or IGHA2, and optionally APOA, HPT, HEP2, ITIH1 and/or C5, are increased with respect to the corresponding reference value is indicative of subclinical atherosclerosis. 2. The method according to claim 1 , wherein step a) comprises determining the protein expression levels of PIGR and/or IGHA2; and one, two, three, four or five biomarkers selected from the list consisting of APOA, HPT, HEP2, ITIH1 and C5. 3. The method according to any of claims 1 or 2, wherein step a) comprises determining the protein expression levels of a plurality of biomarkers selected from the group consisting of: a. PIGR and/or IGHA2, and APOA; b. PIGR and/or IGHA2, and HPT; c. PIGR and/or IGHA2 , and HEP2 ; d. PIGR and/or IGHA2, and C5; e. PIGR and/or IGHA2, and ITIH1 ; f. PIGR and/or IGHA2, APOA and HPT; g. PIGR and/or IGHA2, APOA and HEP2; h. PIGR and/or IGHA2, APOA and C5; i. PIGR and/or IGHA2, APOA and ITIH1 ; j. PIGR and/or IGHA2, HPT and HEP2; k. PIGR and/or IGHA2, HPT and C5; l. PIGR and/or IGHA2, HPT and ITIH1 ; m. PIGR and/or IGHA2, HEP2 and C5; n. PIGR and/or IGHA2, HEP2 and ITIH1 ; o. PIGR and/or IGHA2, APO A, HPT and C5; p. PIGR and/or IGHA2, APOA, HPT and HTH1 ; q. PIGR and/or IGHA2, APOA, HEP2 and C5; r. PIGR and/or IGHA2, APOA, HEP2 and ITIH1 ; s. PIGR and/or IGHA2, HPT, HEP2 and C5; t. PIGR and/or IGHA2, HPT, HEP2 and ITIH1 ; and u. PIGR and/or IGHA2, APOA, HPT and HEP2. 4. The method according to any of claims 1 to 3, wherein said method further comprises determining in said biological sample the protein expression levels of IGHG1; wherein when the levels of IGHG1 in the subject's sample are decreased with respect to a reference value is indicative of subclinical atherosclerosis. 5. The method according to any of claims 1 to 3, wherein IGHA2 levels are relative levels with respect to any of IGHA1 , IGHG1 , IGHG2 or a combination thereof, preferably wherein IGHA2 levels are relative levels with respect to IGHA1 or with respect to the average levels of IGHG1 and IGHG2. 6. The method according to any of claims 1 to 5, wherein said method further comprises conducting a traditional cardiovascular risk score, preferably wherein said traditional cardiovascular risk score is selected from the group consisting of 10y FHS, 30-y FHS, ICHS and the BEWAT scores, more preferably wherein said cardiovascular risk score is 10-y FHS. 7. The method according to any of claims 1 to 6, wherein said method is a method for the screening and/or diagnosis of subclinical atherosclerosis in a subject classified as low risk when conducting a traditional cardiovascular risk score. 8. The method according to any of claims 1 to 7, wherein said biological sample isolated from the subject is a serum, blood or plasma sample, preferably is a serum sample. 9. The method according to any of claims 1 to 8, wherein said subject is a human subject. 10. The method according to any of claims 1 to 9, wherein steps b) and/or c) are implemented by a computer. 11. A data-processing apparatus comprising means adapted for carrying out the steps of a method ol claim 10. 12. A computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps of the method of claim 10. 13. A computer-readable storage medium having stored thereon a computer program according to claim 12. 14. Use of a kit in a method for the screening, diagnosis and/or monitoring of a subject according to any of claims 1 to 10, wherein said kit comprises: a. a reagent for determining the protein expression levels of PIGR and/or IGHA2; and b. optionally, a reagent for determining the protein expression levels of one, two, three, four or five of APOA, HPT, HEP2, ITIH1 or C5; c. optionally, further comprising instructions for the use of said reagents in determining said proteins expression levels in a biological sample isolated from a subject. 15. Use of a kit according to claim 14, the kit comprising reagents adequate for the determination of the protein expression levels of the following biomarkers: i. PIGR and/or IGHA2; ii. optionally, one, two, three, four or five biomarkers selected from APOA, HPT, HEP2, ITIH1 and C5; wherein said kit comprises: a. an affinity reagent for PIGR and/or IGHA2; b. optionally, an affinity reagent for one, two, three four or five of APOA, HPT, HEP2, ITIH1 and C5; c. optionally, further comprising instructions for the use of said reagents in determining said protein expression levels in a biological sample isolated from a subject.

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