Clinical trial NCT02767960: Serum Tenascin-C Concentration in Patients With Acute Coronary Syndrome
Official title: Change of Serum Tenascin-C Concentration and the Relationship With Hs-CRP，cTnI and Prognosis in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Tenascin-C
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with acute coronary syndrome,including STEMI,non-STEMI,and UAP patients.

Brief summary: This study valuates the serum Tenascin-C concentration in patients with 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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Tenascin-C concentration
timeFrame: 12 months
Secondary outcomes:
measure: Relationship between Tenascin-C and high sensitive C reaction protein (hs-CRP) concentration
timeFrame: 12 months
measure: Relationship between Tenascin-C and Troponin-I (Tn-I) concentration
timeFrame: 12 months
measure: MACEs during 12-month follow-up
timeFrame: 12 months
Other outcomes:
Locations:
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Rongchong Huang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/S0002-9440(10)62954-9.
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. doi: 10.1016/j.jacc.2006.03.033. Epub 2006 May 4.
citation: 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.
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. No abstract available.