Serum Tenascin-C Concentration in Patients With Acute Coronary Syndrome

NCT02767960 | Completed DMC

• 1 other identifier: LCKY2016
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Coronary Syndrome

Keywords

Tenascin-C

Outcome Measures

Primary Outcomes (1)

• Serum Tenascin-C concentration

  Serum Tenascin-C concentration in ng/ml

  12 months

Secondary Outcomes (3)

• Relationship between Tenascin-C and high sensitive C reaction protein (hs-CRP) concentration

  12 months

• Relationship between Tenascin-C and Troponin-I (Tn-I) concentration

  12 months

• MACEs during 12-month follow-up

  12 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

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

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Related Publications (4)

• 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.

  PMID: 15972953 BACKGROUND

• 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.

  PMID: 16750702 BACKGROUND

• 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.

  PMID: 19944367 BACKGROUND

• 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.

  PMID: 25965612 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Rongchong Huang, doctor

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)