- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03335514
GALNT4 in Patients With Acute Coronary Syndrome
March 17, 2019 updated by: The First Affiliated Hospital of Dalian Medical University
Changes of GALNT4 and the Relationship With PSGL-1on Monocytes and Hs-CRP in Blood of Patients With Coronary Heart Disease
The expression of GALNT4 in blood with acute coronary syndrome
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Emerging evidences have linked GALNTs to cardiovascular disease or susceptibility to CAD.GALNT4, a member of the GalNAc-Ts family,contributes to the initiation of O-linked.
Polymorphisms in GALNT4 have been linked with incidence of MI in an Irish population, probably that O-glycosylation of PSGL-1 by GalNAc-T4 may be important for many P-selectin mediated inflammation.However, there is few relevant studies about the expression of GALNT4 in patients with acute coronary syndrome.This study valuates the expression of GALNT4 in patients with acute coronary syndrome.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Dalian, Liaoning, China, 116011
- The First Affiliated Hospital of Dalian Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
ALL the 4 groups will be selected.
Description
Inclusion Criteria:
diagnosed as acute coronary syndrome,including STEMI,NSTE-ACS,or diagnosed as SAP by CAG.
- with left ventricular ejection fraction(LVEF)>=45%
- written informed consents are obtained
- admitted within 24 hours after chest pain attacked(except SAP)
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
STEMI
The study population consists of 20 patients with ST-elevated acute myocardial infarction (STEMI,n = 20) 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, 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 and the total RNA was extracted from blood.Realtime PCR was performed to measure the expression of GALNT4.
|
NSTE-ACS
The study population consists of 30 patients with non-ST elevated acute myocardial infarction (NSTE-ACS,n=30) 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, 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 and the total RNA was extracted from blood.Realtime PCR was performed to measure the expression of GALNT4.
|
SAP
The study population consists of 30 patients with stable angina pectoris (SAP, n = 30).
The diagnosis is made according to the criteria of the American Heart Association (AHA, 2014 and 2015).
Patients who had autoimmune diseases, malignancies,chronic or acute infections, severe heart failure (NYHA class 3and 4) and advanced liver or renal diseases are excluded.
|
Blood is obtained into ethylenediaminetetraacetic acid(EDTA) tubes from all subjects via antecubital venepuncture and the total RNA was extracted from blood.Realtime PCR was performed to measure the expression of GALNT4.
|
CONTROL
20 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 Normal group
|
Blood is obtained into ethylenediaminetetraacetic acid(EDTA) tubes from all subjects via antecubital venepuncture and the total RNA was extracted from blood.Realtime PCR was performed to measure the expression of GALNT4.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the expression of GALNT4
Time Frame: 12 months
|
Realtime RCR measure the expression of galnt4 in peripheral blood
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACEs during 12-month follow-up
Time Frame: 12 months
|
All major adverse cardiac events( MACEs) including death, myocardial infarction, heart failure are recorded
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Block H, Ley K, Zarbock A. Severe impairment of leukocyte recruitment in ppGalNAcT-1-deficient mice. J Immunol. 2012 Jun 1;188(11):5674-81. doi: 10.4049/jimmunol.1200392. Epub 2012 Apr 27.
- Taylor DE. Plasmid-mediated tetracycline resistance in Campylobacter jejuni: expression in Escherichia coli and identification of homology with streptococcal class M determinant. J Bacteriol. 1986 Mar;165(3):1037-9. doi: 10.1128/jb.165.3.1037-1039.1986.
- Beaman EM, Brooks SA. The extended ppGalNAc-T family and their functional involvement in the metastatic cascade. Histol Histopathol. 2014 Mar;29(3):293-304. doi: 10.14670/HH-29.293. Epub 2013 Oct 9.
- Braenne I, Civelek M, Vilne B, Di Narzo A, Johnson AD, Zhao Y, Reiz B, Codoni V, Webb TR, Foroughi Asl H, Hamby SE, Zeng L, Tregouet DA, Hao K, Topol EJ, Schadt EE, Yang X, Samani NJ, Bjorkegren JL, Erdmann J, Schunkert H, Lusis AJ; Leducq Consortium CAD Genomicsdouble dagger. Prediction of Causal Candidate Genes in Coronary Artery Disease Loci. Arterioscler Thromb Vasc Biol. 2015 Oct;35(10):2207-17. doi: 10.1161/ATVBAHA.115.306108. Epub 2015 Aug 20.
- O'Halloran AM, Patterson CC, Horan P, Maree A, Curtin R, Stanton A, McKeown PP, Shields DC. Genetic polymorphisms in platelet-related proteins and coronary artery disease: investigation of candidate genes, including N-acetylgalactosaminyltransferase 4 (GALNT4) and sulphotransferase 1A1/2 (SULT1A1/2). J Thromb Thrombolysis. 2009 Feb;27(2):175-84. doi: 10.1007/s11239-008-0196-z. Epub 2008 Feb 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
November 3, 2017
First Submitted That Met QC Criteria
November 6, 2017
First Posted (Actual)
November 7, 2017
Study Record Updates
Last Update Posted (Actual)
March 19, 2019
Last Update Submitted That Met QC Criteria
March 17, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCKY2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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