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Completed

NCT Number: NCT03394092

Serum Concentration of lgG in Patient With Acute Coronary Syndrome

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Dalian Medical University

Dalian, 116011, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantitative measurements the changes of IgG glycosylation

Diagnostic 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.

Primary outcomes

  1. Serum quantitative determination of lgG

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 12 months

    correlation between the serum hs-CRP and lgG

  2. MACEs during 12-month follow-up

    Time frame: 12 months

    Association of quantitative level of lgG with prognosis

  3. The changes of LVEF in two groups

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Dalian Medical University

Other

Collaborators

  • Dalian Institute of Chemical Physics, Chinese Academy of Sciences , Dalian

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2018
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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