Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome

February 6, 2018 updated by: The First Affiliated Hospital of Dalian Medical University

Change of Serum Wnt2 or Wnt4 and the Relationship With Hs-CRP，cTnI and Prognosis in Patients With Acute Coronary Syndrome

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It has been reported that wnt effecory moleculars (wnt2, wnt4, wnt11,wnt10b, DKK1, DKK2) increased in myocardium at acute phase after myocardium infarction in animal experiment. These moleculars can be detected in serum or plasma from human subjects. However, there is few relevant studies about wnt2 and wnt4 concentration in patients with acute coronary syndrome. This study valuates the serum wnt2 and wnt4 concentration in patients with acute coronary syndrome. It will possibly enable to find the relationship between serum wnt2 or wnt4 concentration and Hs-CRP, cTnI and prognosis in patients with Acute Coronary Syndrome.

Study Type

Observational

Enrollment (Anticipated)

450

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

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

.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

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.
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

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 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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum wnt2 and wnt4 concentration
Time Frame: 12 months
Serum wnt2 and wnt4 concentration in ng/ml
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between wnt2 or wnt4 and high sensitive C reaction protein (hs-CRP) concentration
Time Frame: 12 months
Correlation of wnt2 and wnt4 with hs-CRP concentration
12 months
Relationship between wnt2 or wnt4 and Troponin-I (Tn-I) concentration
Time Frame: 12 months
Correlation of wnt2 and wnt4 with Tn-I concentration
12 months
MACEs during 12-month follow-up
Time Frame: 12 months
Association of wnt2 or wnt4 concentration with prognosis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Dalian Medical University

Collaborators

Fudan University

Investigators

  • Principal Investigator: Rongchong Huang, Ph,D, 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)

September 29, 2017

Primary Completion (Anticipated)

September 29, 2018

Study Completion (Anticipated)

March 29, 2019

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJ-KS-KY-2017-104(X)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

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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