Serum Concentration of lgG in Patient With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

Changes in Glycopeptides of Serum Immunoglobulin G in Patients With Acute Myocardial Infarction and the Relationships Between Its Change and Prognosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394092
• Other study ID #: LCKY2017-1
• Status: Completed
• Start date: January 15, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate the changes in glycopeptides of serum immunoglobulin G in patients with acute myocardial infarction and the relationships between its change and prognosis.

Description:

Immunoglobin G (IgG), a highly abundant glycoprotein in serum, is known to participate in blood immune responses.It has been an increasing interest in the analysis of the abnormal glycosylation of human lgG in healthy and disease states, such as autoimmune diseases and cancer.However, there is few relevant studies about the changes in glycopeptides of serum immunoglobulin G in patients with acute myocardial infarction. This study was performed for the frst timeto assess the quantitative changes of serum IgG glycosylation in patients with acute myocardial infarction and the relationships between its change and prognosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosed as STEMI.

• with left ventricular ejection fraction(LVEF)>=45%

• written informed consents are obtained

• admitted within 24 hours after chest pain attacked

Exclusion Criteria:

• complicated with rheumatic heart disease, coronary arteritis, hypertrophic cardiomyopathy or dilated cardiomyopathy

• complicated with malignant tumor,the immune system diseases, blood system diseases, recently (within 2 weeks) taking glucocorticoid drugs, the use of immunosuppressive agents and cerebral infarction

• with acute or chronic infection, surgery or trauma in the last month

• secondary hypertension, severe liver dysfunction,severe renal insufficiency

• with abnormal thyroid function or allergy to iodine agent refusal to sign the informed consent

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Quantitative measurements the changes of IgG glycosylation
Serum (50 each group) is obtained into ethylenediaminetetraacetic acid(EDTA) tubes from all subjects via antecubital venepuncture.Blood is obtained into ethylenediaminetetraacetic acid(EDTA) tubes from all subjects via antecubital venepuncture to assess the quantitative changes of IgG glycosylation by HPLC-MRM at 0 , 3 and 7 days after admission.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian Medical University	Dalian

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University	Dalian Institute of Chemical Physics, Chinese Academy of Sciences , Dalian

Country where clinical trial is conducted

China, 

References & Publications (19)

Bondt A, Rombouts Y, Selman MH, Hensbergen PJ, Reiding KR, Hazes JM, Dolhain RJ, Wuhrer M. Immunoglobulin G (IgG) Fab glycosylation analysis using a new mass spectrometric high-throughput profiling method reveals pregnancy-associated changes. Mol Cell Proteomics. 2014 Nov;13(11):3029-39. doi: 10.1074/mcp.M114.039537. Epub 2014 Jul 8. — View Citation

Bruhns P, Samuelsson A, Pollard JW, Ravetch JV. Colony-stimulating factor-1-dependent macrophages are responsible for IVIG protection in antibody-induced autoimmune disease. Immunity. 2003 Apr;18(4):573-81. — View Citation

Everett BM, Pradhan AD, Solomon DH, Paynter N, Macfadyen J, Zaharris E, Gupta M, Clearfield M, Libby P, Hasan AA, Glynn RJ, Ridker PM. Rationale and design of the Cardiovascular Inflammation Reduction Trial: a test of the inflammatory hypothesis of atherothrombosis. Am Heart J. 2013 Aug;166(2):199-207.e15. doi: 10.1016/j.ahj.2013.03.018. Epub 2013 May 3. — View Citation

Ferrara C, Grau S, Jäger C, Sondermann P, Brünker P, Waldhauer I, Hennig M, Ruf A, Rufer AC, Stihle M, Umaña P, Benz J. Unique carbohydrate-carbohydrate interactions are required for high affinity binding between FcgammaRIII and antibodies lacking core fucose. Proc Natl Acad Sci U S A. 2011 Aug 2;108(31):12669-74. doi: 10.1073/pnas.1108455108. Epub 2011 Jul 18. — View Citation

Gala FA, Morrison SL. V region carbohydrate and antibody expression. J Immunol. 2004 May 1;172(9):5489-94. — View Citation

Harre U, Lang SC, Pfeifle R, Rombouts Y, Frühbeißer S, Amara K, Bang H, Lux A, Koeleman CA, Baum W, Dietel K, Gröhn F, Malmström V, Klareskog L, Krönke G, Kocijan R, Nimmerjahn F, Toes RE, Herrmann M, Scherer HU, Schett G. Glycosylation of immunoglobulin G determines osteoclast differentiation and bone loss. Nat Commun. 2015 Mar 31;6:6651. doi: 10.1038/ncomms7651. — View Citation

Hodoniczky J, Zheng YZ, James DC. Control of recombinant monoclonal antibody effector functions by Fc N-glycan remodeling in vitro. Biotechnol Prog. 2005 Nov-Dec;21(6):1644-52. — View Citation

Hong Q, Lebrilla CB, Miyamoto S, Ruhaak LR. Absolute quantitation of immunoglobulin G and its glycoforms using multiple reaction monitoring. Anal Chem. 2013 Sep 17;85(18):8585-93. doi: 10.1021/ac4009995. Epub 2013 Aug 30. — View Citation

Kaneko Y, Nimmerjahn F, Ravetch JV. Anti-inflammatory activity of immunoglobulin G resulting from Fc sialylation. Science. 2006 Aug 4;313(5787):670-3. — View Citation

Kazuno S, Furukawa J, Shinohara Y, Murayama K, Fujime M, Ueno T, Fujimura T. Glycosylation status of serum immunoglobulin G in patients with prostate diseases. Cancer Med. 2016 Jun;5(6):1137-46. doi: 10.1002/cam4.662. Epub 2016 Feb 16. — View Citation

Moore JS, Wu X, Kulhavy R, Tomana M, Novak J, Moldoveanu Z, Brown R, Goepfert PA, Mestecky J. Increased levels of galactose-deficient IgG in sera of HIV-1-infected individuals. AIDS. 2005 Mar 4;19(4):381-9. — View Citation

Plomp R, Dekkers G, Rombouts Y, Visser R, Koeleman CA, Kammeijer GS, Jansen BC, Rispens T, Hensbergen PJ, Vidarsson G, Wuhrer M. Hinge-Region O-Glycosylation of Human Immunoglobulin G3 (IgG3). Mol Cell Proteomics. 2015 May;14(5):1373-84. doi: 10.1074/mcp.M114.047381. Epub 2015 Mar 10. — View Citation

Quast I, Keller CW, Maurer MA, Giddens JP, Tackenberg B, Wang LX, Münz C, Nimmerjahn F, Dalakas MC, Lünemann JD. Sialylation of IgG Fc domain impairs complement-dependent cytotoxicity. J Clin Invest. 2015 Nov 2;125(11):4160-70. doi: 10.1172/JCI82695. Epub 2015 Oct 5. — View Citation

Russell AC, Šimurina M, Garcia MT, Novokmet M, Wang Y, Rudan I, Campbell H, Lauc G, Thomas MG, Wang W. The N-glycosylation of immunoglobulin G as a novel biomarker of Parkinson's disease. Glycobiology. 2017 May 1;27(5):501-510. doi: 10.1093/glycob/cwx022. — View Citation

Saldova R, Royle L, Radcliffe CM, Abd Hamid UM, Evans R, Arnold JN, Banks RE, Hutson R, Harvey DJ, Antrobus R, Petrescu SM, Dwek RA, Rudd PM. Ovarian cancer is associated with changes in glycosylation in both acute-phase proteins and IgG. Glycobiology. 2007 Dec;17(12):1344-56. Epub 2007 Sep 20. — View Citation

Shinkawa T, Nakamura K, Yamane N, Shoji-Hosaka E, Kanda Y, Sakurada M, Uchida K, Anazawa H, Satoh M, Yamasaki M, Hanai N, Shitara K. The absence of fucose but not the presence of galactose or bisecting N-acetylglucosamine of human IgG1 complex-type oligosaccharides shows the critical role of enhancing antibody-dependent cellular cytotoxicity. J Biol Chem. 2003 Jan 31;278(5):3466-73. Epub 2002 Nov 8. — View Citation

Yang N, Goonatilleke E, Park D, Song T, Fan G, Lebrilla CB. Quantitation of Site-Specific Glycosylation in Manufactured Recombinant Monoclonal Antibody Drugs. Anal Chem. 2016 Jul 19;88(14):7091-100. doi: 10.1021/acs.analchem.6b00963. Epub 2016 Jun 24. — View Citation

Yi CH, Weng HL, Zhou FG, Fang M, Ji J, Cheng C, Wang H, Liebe R, Dooley S, Gao CF. Elevated core-fucosylated IgG is a new marker for hepatitis B virus-related hepatocellular carcinoma. Oncoimmunology. 2015 Jul 7;4(12):e1011503. eCollection 2015 Dec. — View Citation

Zou G, Ochiai H, Huang W, Yang Q, Li C, Wang LX. Chemoenzymatic synthesis and Fc? receptor binding of homogeneous glycoforms of antibody Fc domain. Presence of a bisecting sugar moiety enhances the affinity of Fc to Fc?IIIa receptor. J Am Chem Soc. 2011 Nov 23;133(46):18975-91. doi: 10.1021/ja208390n. Epub 2011 Nov 1. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum quantitative determination of lgG	Quantitative measurements the changes of serum IgG glycosylation by HPLC-MRM	12 months
Secondary	Relationship between the serum hs-CRP and the quantitative level of lgG glycopeptides in peripheral blood.	correlation between the serum hs-CRP and lgG	12 months
Secondary	MACEs during 12-month follow-up	Association of quantitative level of lgG with prognosis	12 months
Secondary	The changes of LVEF in two groups	Association of quantitative level of lgG with the changes of cardiac function	12 months