NCT03394092

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

January 3, 2018

Last Update Submit

March 17, 2019

Conditions

Acute Coronary Syndrome

Keywords

immunoglobulin G

Outcome Measures

Primary Outcomes (1)

  • Serum quantitative determination of lgG

    Quantitative measurements the changes of serum IgG glycosylation by HPLC-MRM

    12 months

Secondary Outcomes (3)

  • Relationship between the serum hs-CRP and the quantitative level of lgG glycopeptides in peripheral blood.

    12 months

  • MACEs during 12-month follow-up

    12 months

  • The changes of LVEF in two groups

    12 months

Study Arms (2)

STEMI

The study population consists of 50 patients with ST-elevated acute myocardial infarction (STEMI) who are admitted within 24 hours after chest pain attack. They will all undergo coronary angiography. The diagnosis is made according to American Heart Association (AHA, 2014 and 2015) guidelines. Patients who had autoimmune diseases, malignancies, chronic or acute infections, asthma, severe heart failure (NYHA class 3 and 4) and advanced liver or renal diseases are excluded. 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.

Diagnostic Test: Quantitative measurements the changes of IgG glycosylation

Control

50 age and body mass index matched healthy subjects with neither coronary artery disease nor any of the components of the metabolic syndrome are studied as control group.Quantitative changes of IgG glycosylation be measured only once on admission.

Diagnostic Test: Quantitative measurements the changes of IgG glycosylation

Interventions

Quantitative measurements the changes of IgG glycosylationDIAGNOSTIC_TEST

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.

ControlSTEMI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

50 with ST-elevation myocardial infarction (STEMI) patients and 50 age and body mass index matched healthy subjects with neither coronary artery disease nor any of the components of the metabolic syndrome are studied as Control group. They will all undergo coronary angiography.The diagnosis is made according to American Heart Association(AHA, 2014 and 2015) guidelines. Patients who had autoimmune diseases, malignancies, chronic or acute infections, asthma, severe heart failure (NYHA class 3 and 4) and advanced liver or renal diseases are excluded.

You may qualify if:

  • \- diagnosed as STEMI.
  • with left ventricular ejection fraction（LVEF）\>=45%
  • written informed consents are obtained
  • admitted within 24 hours after chest pain attacked

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, 116011, China

Location

Related Publications (19)

  • 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. doi: 10.1074/jbc.M210665200. Epub 2002 Nov 8.

    PMID: 12427744BACKGROUND

  • 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. doi: 10.1021/bp050228w.

    PMID: 16321047BACKGROUND

  • Ferrara C, Grau S, Jager C, Sondermann P, Brunker P, Waldhauer I, Hennig M, Ruf A, Rufer AC, Stihle M, Umana 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.

    PMID: 21768335BACKGROUND

  • Kaneko Y, Nimmerjahn F, Ravetch JV. Anti-inflammatory activity of immunoglobulin G resulting from Fc sialylation. Science. 2006 Aug 4;313(5787):670-3. doi: 10.1126/science.1129594.

    PMID: 16888140BACKGROUND

  • 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. doi: 10.1016/s1074-7613(03)00080-3.

    PMID: 12705859BACKGROUND

  • Quast I, Keller CW, Maurer MA, Giddens JP, Tackenberg B, Wang LX, Munz C, Nimmerjahn F, Dalakas MC, Lunemann 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.

    PMID: 26436649BACKGROUND

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

    PMID: 22004528BACKGROUND

  • 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.

    PMID: 23895801BACKGROUND

  • Gala FA, Morrison SL. V region carbohydrate and antibody expression. J Immunol. 2004 May 1;172(9):5489-94. doi: 10.4049/jimmunol.172.9.5489.

    PMID: 15100290BACKGROUND

  • 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.

    PMID: 25004930BACKGROUND

  • 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.

    PMID: 25759508BACKGROUND

  • Harre U, Lang SC, Pfeifle R, Rombouts Y, Fruhbeisser S, Amara K, Bang H, Lux A, Koeleman CA, Baum W, Dietel K, Grohn F, Malmstrom V, Klareskog L, Kronke 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.

    PMID: 25825024BACKGROUND

  • 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. doi: 10.1097/01.aids.0000161767.21405.68.

    PMID: 15750391BACKGROUND

  • Russell AC, Simurina 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.

    PMID: 28334832BACKGROUND

  • 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. doi: 10.1093/glycob/cwm100. Epub 2007 Sep 20.

    PMID: 17884841BACKGROUND

  • 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.

    PMID: 26880719BACKGROUND

  • 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. doi: 10.1080/2162402X.2015.1011503. eCollection 2015 Dec.

    PMID: 26587313BACKGROUND

  • 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.

    PMID: 23944609BACKGROUND

  • 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.

    PMID: 27311011BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 9, 2018

Study Start

January 15, 2018

Primary Completion

January 15, 2019

Study Completion

March 1, 2019

Last Updated

March 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)