Serum Tenascin-C Concentration in Patients With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

Change of Serum Tenascin-C Concentration and the Relationship With Hs-CRP，cTnI and Prognosis in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767960
• Other study ID #: LCKY2016
• Status: Completed
• Phase: N/A
• First received: May 3, 2016
• Last updated: July 29, 2017
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study valuates the serum Tenascin-C concentration in patients with acute coronary syndrome.

Description:

It is found that Tenascin-C plays an important role in ventricular remodeling, heart failure, aortic dissection, rheumatic heart disease and other cardiovascular diseases, which may be a new marker for the diagnosis and prognosis prediction of these diseases. However, there is few relevant studies about the Tenascin-C concentration in patients with acute coronary syndrome.This study valuates the serum Tenascin-C concentration in patients with acute coronary syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

.diagnosed as acute coronary syndrome,including STEMI,non-STEMI,and UAP.

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Fujimoto N, Onishi K, Sato A, Terasaki F, Tsukada B, Nozato T, Yamada T, Imanaka-Yoshida K, Yoshida T, Ito M, Hiroe M. Incremental prognostic values of serum tenascin-C levels with blood B-type natriuretic peptide testing at discharge in patients with dilated cardiomyopathy and decompensated heart failure. J Card Fail. 2009 Dec;15(10):898-905. doi: 10.1016/j.cardfail.2009.06.443. Epub 2009 Aug 26. — View Citation

Nozato T, Sato A, Hikita H, Takahashi A, Imanaka-Yoshida K, Yoshida T, Aonuma K, Hiroe M. Impact of serum tenascin-C on the aortic healing process during the chronic stage of type B acute aortic dissection. Int J Cardiol. 2015 Jul 15;191:97-9. doi: 10.1016/j.ijcard.2015.05.009. Epub 2015 May 6. — View Citation

Sato A, Aonuma K, Imanaka-Yoshida K, Yoshida T, Isobe M, Kawase D, Kinoshita N, Yazaki Y, Hiroe M. Serum tenascin-C might be a novel predictor of left ventricular remodeling and prognosis after acute myocardial infarction. J Am Coll Cardiol. 2006 Jun 6;47(11):2319-25. Epub 2006 May 4. — View Citation

Tamaoki M, Imanaka-Yoshida K, Yokoyama K, Nishioka T, Inada H, Hiroe M, Sakakura T, Yoshida T. Tenascin-C regulates recruitment of myofibroblasts during tissue repair after myocardial injury. Am J Pathol. 2005 Jul;167(1):71-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Tenascin-C concentration	Serum Tenascin-C concentration in ng/ml	12 months
Secondary	Relationship between Tenascin-C and high sensitive C reaction protein (hs-CRP) concentration	With or without association between them	12 months
Secondary	Relationship between Tenascin-C and Troponin-I (Tn-I) concentration	With or without association between them	12 months
Secondary	MACEs during 12-month follow-up	All major adverse cardiac events( MACEs) including death, myocardial infarction, angina, heart failure are recorded.	12 months