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Serum Concentration of lgG in Patient With Acute Coronary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394092
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Dalian Institute of Chemical Physics, Chinese Academy of Sciences , Dalian
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Diagnostic Test: Quantitative measurements the changes of IgG glycosylation

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Changes in Glycopeptides of Serum Immunoglobulin G in Patients With Acute Myocardial Infarction and the Relationships Between Its Change and Prognosis
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
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
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.

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
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 Outcome Measures :
  1. Serum quantitative determination of lgG [ Time Frame: 12 months ]
    Quantitative measurements the changes of serum IgG glycosylation by HPLC-MRM


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394092


Locations
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China
The First Affiliated Hospital of Dalian Medical University
Dalian, China, 116011
Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University
Dalian Institute of Chemical Physics, Chinese Academy of Sciences , Dalian
Publications:

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Responsible Party: The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT03394092    
Other Study ID Numbers: LCKY2017-1
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital of Dalian Medical University:
immunoglobulin G
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases