Serum Tenascin-C Concentration in Patients With Acute Coronary Syndrome

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

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

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • The First Affiliated Hospital of Dalian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with acute coronary syndrome,including STEMI,non-STEMI,and UAP patients.

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
STEMI group; The study population consists of 30 patients with ST-elevated acute myocardial infarction (STEMI,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, asthma, severe heart failure (NYHA class 3 and 4) and advanced liver or renal diseases are excluded.
NSTEMI group; The study population consists of 30 patients with non-ST elevated acute myocardial infarction (NSTEMI,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, asthma, severe heart failure (NYHA class 3 and 4) and advanced liver or renal diseases are excluded.
UAP group; The study population consists of 30 patients with unstable angina pectoris (UAP, n = 30). They will all undergo coronary angiography for the diagnosis of acute coronary syndrome. 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, asthma, severe heart failure (NYHA class 3 and 4) and advanced liver or renal diseases are excluded.
control group; 15 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Tenascin-C concentration	Serum Tenascin-C concentration in ng/ml	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between Tenascin-C and high sensitive C reaction protein (hs-CRP) concentration	With or without association between them	12 months
Relationship between Tenascin-C and Troponin-I (Tn-I) concentration	With or without association between them	12 months
MACEs during 12-month follow-up	All major adverse cardiac events( MACEs) including death, myocardial infarction, angina, heart failure are recorded.	12 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Dalian Medical University
• Investigators: Principal Investigator: Rongchong Huang, doctor, The First Affiliated Hospital of Dalian Medical University

Publications and helpful links

General Publications

• 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. doi: 10.1016/S0002-9440(10)62954-9.
• 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. doi: 10.1016/j.jacc.2006.03.033. Epub 2006 May 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.
• 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. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 29, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Tenascin-C
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: LCKY2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No