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Serum Concentration of lgG in Patient With Acute Coronary Syndrome

Completed
Conditions
Acute Coronary Syndrome
Interventions
Diagnostic Test: Quantitative measurements the changes of IgG glycosylation
Registration Number
NCT03394092
Lead Sponsor
The First Affiliated Hospital of Dalian Medical University
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
ControlQuantitative measurements the changes of IgG glycosylation50 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.
STEMIQuantitative measurements the changes of IgG glycosylationThe 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.
Primary Outcome Measures
NameTimeMethod
Serum quantitative determination of lgG12 months

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

Secondary Outcome Measures
NameTimeMethod
MACEs during 12-month follow-up12 months

Association of quantitative level of lgG with prognosis

The changes of LVEF in two groups12 months

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

Relationship between the serum hs-CRP and the quantitative level of lgG glycopeptides in peripheral blood.12 months

correlation between the serum hs-CRP and lgG

Trial Locations

Locations (1)

The First Affiliated Hospital of Dalian Medical University

🇨🇳

Dalian, China

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