Acute Coronary SyndromeNCT02767960
Serum Tenascin-C Concentration in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
This study valuates the serum Tenascin-C concentration in patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Jul 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute coronary syndrome,including STEMI,non-STEMI,and UAP patients.
Who may be able to join
- .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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
About this study
Official title: 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.
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.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Tenascin-C
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Serum Tenascin-C concentration
Serum Tenascin-C concentration in ng/ml
Measured: 12 months
Secondary outcomes (3)
Relationship between Tenascin-C and high sensitive C reaction protein (hs-CRP) concentration
With or without association between them
Measured: 12 months
Relationship between Tenascin-C and Troponin-I (Tn-I) concentration
With or without association between them
Measured: 12 months
MACEs during 12-month follow-up
All major adverse cardiac events( MACEs) including death, myocardial infarction, angina, heart failure are recorded.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rchuang, The First Affiliated Hospital of Dalian Medical University
- Investigators
- Rongchong Huang, doctor, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767960
- Sponsor's protocol ID
- LCKY2016
- Status last verified
- Jul 2017
- First submitted
- 3 May 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 15972953Sato 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 16750702Fujimoto 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 19944367Nozato 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Serum Tenascin-C Concentration and the Relationship With Hs-CRP，cTnI and Prognosis in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02767960
- Acronym / sponsor ID
- LCKY2016
- Conditions
- Acute Coronary Syndrome
- Keywords
- Tenascin-C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute coronary syndrome,including STEMI,non-STEMI,and UAP patients.
Key inclusion criteria (4 listed)
- .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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Tenascin-C concentration
Time frame: 12 months
Serum Tenascin-C concentration in ng/ml
3 secondary outcomes
Relationship between Tenascin-C and high sensitive C reaction protein (hs-CRP) concentration
Time frame: 12 months
Relationship between Tenascin-C and Troponin-I (Tn-I) concentration
Time frame: 12 months
MACEs during 12-month follow-up
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Background: PubMed 15972953Tamaoki 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.
- Background: PubMed 16750702Sato 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.
- Background: PubMed 19944367Fujimoto 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.
- Background: PubMed 25965612Nozato 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongchong Huang, doctor principal investigator
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Tenascin-C concentration (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02767960, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.