AzTrials
AzTrials

Acute Coronary SyndromeNCT03342131

Serum Concentration of Wnt2 and Wnt4 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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Circulating wnt 2 and wnt 4 concentration
How many people
450 participants
Where
1 siteChina
Study dates
29 Sep 2017to 29 Mar 2019
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 40 to 80 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • .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

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

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Circulating wnt 2 and wnt 4 concentration
Keywords
Wnt signaling
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.

  • 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.

Study groups in NCT03342131
Study groupRoleWhat they receive
STEMI groupThe 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.
Receives: Other: Circulating wnt 2 and wnt 4 concentration
NST-ACS groupThe 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.
Receives: Other: Circulating wnt 2 and wnt 4 concentration
Control group150 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.
Receives: Other: Circulating wnt 2 and wnt 4 concentration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum wnt2 and wnt4 concentration

    Serum wnt2 and wnt4 concentration in ng/ml

    Measured: 12 months

Secondary outcomes (3)

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

    Correlation of wnt2 and wnt4 with hs-CRP concentration

    Measured: 12 months

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

    Correlation of wnt2 and wnt4 with Tn-I concentration

    Measured: 12 months

  3. MACEs during 12-month follow-up

    Association of wnt2 or wnt4 concentration with prognosis

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2017
  2. Study start29 Sep 2017
  3. Primary completion29 Sep 2018 (estimated)
  4. Study completion29 Mar 2019 (estimated)

Resources

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
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03342131
Sponsor's protocol ID
PJ-KS-KY-2017-104(X)
Status last verified
Sep 2017
First submitted
9 Nov 2017
Last updated
8 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We will publish the paper to described the data and share with other researchers

Publications

  • 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.

    PubMed 21324930

  • 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.

    PubMed 19720407

  • 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.

    PubMed 23359112

  • 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.

    PubMed 16621466

  • 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.

    PubMed 26321050

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

    PubMed 12549854

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 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2018. 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?

Results are not available in the source record.

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?

Serum wnt2 and wnt4 concentration (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 NCT03342131, which also lists 6 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 8 Feb 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in