Acute Coronary SyndromeNCT03335514
GALNT4 in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
The expression of GALNT4 in blood with acute coronary syndrome Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- expression of GALNT4
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ALL the 4 groups will be selected.
Who may be able to join
- 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)
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
About this study
Official title: 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
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- expression of GALNT4
- Keywords
- GALNT4
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: Diagnostic Test: expression of GALNT4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the expression of GALNT4
Realtime RCR measure the expression of galnt4 in peripheral blood
Measured: 12 months
Secondary outcomes (1)
MACEs during 12-month follow-up
All major adverse cardiac events( MACEs) including death, myocardial infarction, heart failure are recorded
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335514
- Sponsor's protocol ID
- LCKY2017
- Status last verified
- Mar 2019
- First submitted
- 3 Nov 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22544932Taylor 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.
PubMed 3005233Beaman 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.
PubMed 24105335Braenne 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.
PubMed 26293461O'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.
PubMed 18259693
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of GALNT4 and the Relationship With PSGL-1on Monocytes and Hs-CRP in Blood of Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT03335514
- Acronym / sponsor ID
- LCKY2017
- Conditions
- Acute Coronary Syndrome
- Keywords
- GALNT4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The expression of GALNT4 in blood with acute coronary syndrome
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | Diagnostic Test: expression of GALNT4The 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. |
| NSTE-ACS | – | Diagnostic Test: expression of GALNT4The 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. |
| SAP | – | Diagnostic Test: expression of GALNT4The 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. |
| CONTROL | – | Diagnostic Test: expression of GALNT420 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALL the 4 groups will be selected.
Key inclusion criteria (4 listed)
- diagnosed as acute coronary syndrome,including STEMI,NSTE-ACS,or diagnosed as SAP by CAG.
Key exclusion criteria (6 listed)
- • complicated with rheumatic heart disease, coronary arteritis, hypertrophic cardiomyopathy or dilated cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| expression of GALNT4Blood 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. | Diagnostic test | CONTROL, NSTE-ACS, SAP, STEMI |
Primary outcome
the expression of GALNT4
Time frame: 12 months
Realtime RCR measure the expression of galnt4 in peripheral blood
1 secondary outcome
MACEs during 12-month follow-up
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Background: PubMed 22544932Block 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.
- Background: PubMed 3005233Taylor 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.
- Background: PubMed 24105335Beaman 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.
- Background: PubMed 26293461Braenne 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.
- Background: PubMed 18259693O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the expression of GALNT4 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335514, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.