NCT03342131

Brief Summary

This study aims to find the change of serum wnt effectory moleculars and the association with Hs-CRP，cTnI and Prognosis in Patients with Acute Coronary Syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

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 29, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2019

Completed
Last Updated

February 8, 2018

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

November 9, 2017

Last Update Submit

February 6, 2018

Conditions

Acute Coronary Syndrome

Keywords

Wnt signaling

Outcome Measures

Primary Outcomes (1)

  • Serum wnt2 and wnt4 concentration

    Serum wnt2 and wnt4 concentration in ng/ml

    12 months

Secondary Outcomes (3)

  • Relationship between wnt2 or wnt4 and high sensitive C reaction protein (hs-CRP) concentration

    12 months

  • Relationship between wnt2 or wnt4 and Troponin-I (Tn-I) concentration

    12 months

  • MACEs during 12-month follow-up

    12 months

Study Arms (3)

STEMI group

The study population consists of 150 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 (150 each group) is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture to explore circulating wnt 2 and wnt 4 concentration by ELISA at 0 , 7days and 12 months after admission.

Other: Circulating wnt 2 and wnt 4 concentration

NST-ACS group

The study population consists of 150 patients with non-ST elevated acute myocardial infarction (NST-ACS) including unstable angina pectoris (UAP),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 (150 each group) is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture to explore circulating wnt 2 and wnt 4 concentration by ELISA at 0 , 7days and 12 months after admission.

Other: Circulating wnt 2 and wnt 4 concentration

Control group

150 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. Circulation wnt2 and wnt4 concentration in Control group will be measured only once with 24h after admission.

Other: Circulating wnt 2 and wnt 4 concentration

Interventions

Circulating wnt 2 and wnt 4 concentrationOTHER

Blood (150 each group) is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture to explore circulating wnt 2 and wnt 4 concentration by ELISA. Continuous wnt2 and wnt4 concentration are measured in all patients with STEMI at 0 , 7days and 12 months after admission. Other patients with acute syndrome system are measured Wnt 2 and wnt4 only once within 24h after admission. Wnt2 and wnt4 concentration in Control group will be measured only once with 24h after admission.

Control groupNST-ACS groupSTEMI group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute coronary syndrome,including STEMI and NST-ACS group patients

You may qualify if:

  • diagnosed as acute coronary syndrome, including STEMI and NST-ACS.
  • with left ventricular ejection fraction（LVEF）\>=45%
  • written informed consents are obtained
  • admitted within 24 hours after chest pain attacked

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 (6)

  • Aisagbonhi O, Rai M, Ryzhov S, Atria N, Feoktistov I, Hatzopoulos AK. Experimental myocardial infarction triggers canonical Wnt signaling and endothelial-to-mesenchymal transition. Dis Model Mech. 2011 Jul;4(4):469-83. doi: 10.1242/dmm.006510. Epub 2011 Feb 14.

    PMID: 21324930RESULT

  • Perez Castrillon JL, San Miguel A, Vega G, Abad L, Andres Domingo M, Gonzalez Sagredo M, de Luis D, Duenas-Laita A. Levels of DKK1 in patients with acute myocardial infarction and response to atorvastatin. Int J Cardiol. 2010 Nov 5;145(1):164-5. doi: 10.1016/j.ijcard.2009.07.025. Epub 2009 Aug 31.

    PMID: 19720407RESULT

  • Wang L, Hu XB, Zhang W, Wu LD, Liu YS, Hu B, Bi CL, Chen YF, Liu XX, Ge C, Zhang Y, Zhang M. Dickkopf-1 as a novel predictor is associated with risk stratification by GRACE risk scores for predictive value in patients with acute coronary syndrome: a retrospective research. PLoS One. 2013;8(1):e54731. doi: 10.1371/journal.pone.0054731. Epub 2013 Jan 24.

    PMID: 23359112RESULT

  • Alexandrovich A, Arno M, Patient RK, Shah AM, Pizzey JA, Brewer AC. Wnt2 is a direct downstream target of GATA6 during early cardiogenesis. Mech Dev. 2006 Apr;123(4):297-311. doi: 10.1016/j.mod.2006.02.002. Epub 2006 Apr 18.

    PMID: 16621466RESULT

  • Caprioli A, Villasenor A, Wylie LA, Braitsch C, Marty-Santos L, Barry D, Karner CM, Fu S, Meadows SM, Carroll TJ, Cleaver O. Wnt4 is essential to normal mammalian lung development. Dev Biol. 2015 Oct 15;406(2):222-34. doi: 10.1016/j.ydbio.2015.08.017. Epub 2015 Aug 29.

    PMID: 26321050RESULT

  • Goodwin AM, D'Amore PA. Wnt signaling in the vasculature. Angiogenesis. 2002;5(1-2):1-9. doi: 10.1023/a:1021563510866.

    PMID: 12549854RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Rongchong Huang, Ph,D

    The First Affiliated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 14, 2017

Study Start

September 29, 2017

Primary Completion

September 29, 2018

Study Completion

March 29, 2019

Last Updated

February 8, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

We will publish the paper to described the data and share with other researchers

Locations

CN(1)