AzTrials
AzTrials

Acute Coronary SyndromeNCT03394092

Serum Concentration of lgG in Patient With Acute Coronary Syndrome

An observational study of Acute Coronary Syndrome, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Quantitative measurements the changes of IgG glycosylation
How many people
100 participants
Where
1 siteChina
Study dates
15 Jan 2018to 1 Mar 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, 116011

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
Quantitative measurements the changes of IgG glycosylation
Keywords
immunoglobulin G
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03394092
Study groupRoleWhat they receive
STEMIThe 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.
Receives: Diagnostic Test: Quantitative measurements the changes of IgG glycosylation
Control50 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.
Receives: Diagnostic Test: Quantitative measurements the changes of IgG glycosylation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum quantitative determination of lgG

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

    Measured: 12 months

Secondary outcomes (3)

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

    correlation between the serum hs-CRP and lgG

    Measured: 12 months

  2. MACEs during 12-month follow-up

    Association of quantitative level of lgG with prognosis

    Measured: 12 months

  3. The changes of LVEF in two groups

    Association of quantitative level of lgG with the changes of cardiac function

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2018
  2. Study start15 Jan 2018
  3. Primary completion15 Jan 2019
  4. Study completion1 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03394092
Sponsor's protocol ID
LCKY2017-1
Status last verified
Mar 2019
First submitted
3 Jan 2018
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12427744

  • 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.

    PubMed 16321047

  • 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.

    PubMed 21768335

  • 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.

    PubMed 16888140

  • 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.

    PubMed 12705859

  • 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.

    PubMed 26436649

  • 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.

    PubMed 22004528

  • 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.

    PubMed 23895801

  • 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.

    PubMed 15100290

  • 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.

    PubMed 25004930

  • 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.

    PubMed 25759508

  • 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.

    PubMed 25825024

  • 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.

    PubMed 15750391

  • 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.

    PubMed 28334832

  • 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.

    PubMed 17884841

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum quantitative determination of lgG (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03394092, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

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