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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Diagnostic test: expression of GALNT4
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.
Diagnostic test: expression of GALNT4
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
Diagnostic test: expression of GALNT4
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Dalian Medical University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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