NCT03335514

Brief Summary

The expression of GALNT4 in blood with acute coronary syndrome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

November 3, 2017

Last Update Submit

March 17, 2019

Conditions

Keywords

GALNT4

Outcome Measures

Primary Outcomes (1)

  • the expression of GALNT4

    Realtime RCR measure the expression of galnt4 in peripheral blood

    12 months

Secondary Outcomes (1)

  • MACEs during 12-month follow-up

    12 months

Study Arms (4)

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.

Diagnostic Test: 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.

Diagnostic Test: 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.

Diagnostic Test: 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

Diagnostic Test: expression of GALNT4

Interventions

expression of GALNT4DIAGNOSTIC_TEST

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.

CONTROLNSTE-ACSSAPSTEMI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ALL the 4 groups will be selected.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Related Publications (5)

  • 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.

    PMID: 22544932BACKGROUND
  • 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.

    PMID: 3005233BACKGROUND
  • 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.

    PMID: 24105335BACKGROUND
  • 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.

    PMID: 26293461BACKGROUND
  • 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.

    PMID: 18259693BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 7, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

March 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations