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CompletedNCT02767960Updated Aug 1, 2017

Serum Tenascin-C Concentration in Patients With Acute Coronary Syndrome

An observational study in Acute Coronary Syndrome, sponsored by The First Affiliated Hospital of Dalian Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by The First Affiliated Hospital of Dalian Medical University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
183
Ages
18 Years to 80 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Acute Coronary Syndrome

Keywords

  • Tenascin-C
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In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 183 is below the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

The First Affiliated Hospital of Dalian Medical University is the lead sponsor of 41 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
183 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Serum Tenascin-C concentration

    Serum Tenascin-C concentration in ng/ml

    Time frame: 12 months

Secondary outcomes

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

    With or without association between them

    Time frame: 12 months

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

    With or without association between them

    Time frame: 12 months

  3. MACEs during 12-month follow-up

    All major adverse cardiac events( MACEs) including death, myocardial infarction, angina, heart failure are recorded.

    Time frame: 12 months

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Study locations

1 site
  • The First Affiliated Hospital of Dalian Medical University
    Dalian, Liaoning 116011, China
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References and documents

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. PubMed 15972953 ↗
  • 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. PubMed 16750702 ↗
  • 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. PubMed 19944367 ↗
  • 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. PubMed 25965612 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02767960
Lead sponsor
The First Affiliated Hospital of Dalian Medical University
Responsible party
Rchuang (Professor, The First Affiliated Hospital of Dalian Medical University) — Principal investigator
First posted
May 11, 2016
Start date
May 2016
Primary completion
Jan 2017
Completion
Jul 2017
Last update
Aug 1, 2017

Study contacts

Rongchong Huang, doctor
principal investigator · The First Affiliated Hospital of Dalian Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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