Stable AnginaNCT02179047
Correlational Study on the Biomarkers Application to the Prediction and Diagnosis of Cardiovascular Diseases
An observational study of Stable Angina, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
Through the literature review , we pick out a series of forward-looking biological indicators as follows : 1. NGAL 2. Cystatin C: 3. Galectin-3: 4. Copeptin: 5. MR-Pro ANP: 6. sST2: Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Stable Angina
- What is being tested?
- coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 214 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with stable angina who received coronary angiography.
Who may be able to join
- stable angina who eligible for coronary angiography after non-invasive stress test.
Who cannot join
- intolerance to procedure or contarst medium.
Trial locations and contacts
1 site in 1 country.
About this study
Through the literature review , we pick out a series of forward-looking biological indicators as follows :
- NGAL
- Cystatin C:
- Galectin-3:
- Copeptin:
- MR-Pro ANP:
- sST2:
Read the detailed description
- NGAL (Neutrophil Gelatinase Associated Lipocalin): in the cardiovascular system , NGAL and endothelial cell apoptosis , atherosclerosis , and abdominal aortic aneurysm associated with thrombosis of a relationship. Heart and kidney complications in common a number of studies have demonstrated that NGAL in acute heart failure , cardiac catheterization / angiography management, and diagnostic usefulness of acute coronary artery disease and heart surgery , and how to make NGAL may pathological processes in the cardiovascular play a role. In the past studies have also demonstrated in sepsis (sepsis), cardiopulmonary around to support cardiac surgery, caused by acute renal developer injury and renal transplant patients and other studies confirm this early detection of serum creatinine more acute kidney injury . So we tried to make the results in this study . (2) Cystatin C: Chronic kidney disease is a cardiovascular morbidity and mortality risk and a significant global health problem. Has been used to estimate renal function , serum creatinine, can be used instead . In several studies have shown to be more sensitive than that for predicting eGFRcreat serum creatinine or adverse events. This parameter also showed greater diagnostic sensitivity for the detection of mild renal damage . Cystatin C and metabolic syndrome and cardiovascular risk factors is also a correlation study confirmed (M. Magnusson et.al, 2013). Therefore , Cystatin C is emerging as a new biomarker for cardiovascular disease. (3) Galectin-3: has proven to be a marker of myocardial fibrosis, Lars Gullestad , who in 2012 also found that Galectin-3 is mainly predictive of ischemic etiology . elderly patients with systolic heart failure death. And approved by the U.S. Food and Drug Administration to help in the prognosis of patients with heart failure in 2011 . Research has also pointed out that , Galectin-3 and there is a positive correlation between renal injury , and the correlation is not affected by whether the patients suffering from heart failure while affected. (4) Copeptin: Copeptin was considered non -specific stress response of the marker , and may also have been proposed various non- cardiovascular monitoring and early warning and cardiovascular diseases ( coronary artery disease, heart failure and acute ) , etc., in a previous study , including patients with acute myocardial infarction was found with Copeptin related , and there Copeptin associated left ventricular ejection fraction (LVEF), and also the follow-up patients found to have a direct correlation with left ventricular volume, and is considered poor prognostic factor of death. (5) MR-Pro ANP (midregional-Pro atrial natriuretic peptide): discovery and diagnosis of heart failure can be predicted in 1984, is a major discovery in the field of biological indicators of heart , but also a milestone, Elif Elmas et al found that when the 2011 MR-Pro ANP in patients suffering from cardiovascular disease as a diagnosis of myocardial fibrosis new biological indicators. Past research has also pointed out that can be used to predict lower respiratory tract infections and pneumonia, long and short-term mortality, Alzheimer's disease, and can diagnose sepsis and bacterial shock and prognosis prediction . (6) sST2 (somatostatin2): Excessive sST2 may cause abnormal cardiac hypertrophy , fibrosis, and heart failure . Clinically, symptoms of heart failure with a high concentration of the patients diagnosed with sST2 severity determined correlations to predict increased risk of complications. Past research indicates measured values sST2 patients suffering from cardiovascular disease increased Jie phenomenon, and found that the measured values sST severity of cardiovascular disease 2 was positively correlated, has now been approved for use in patients with cardiovascular disease and new biomarkers predictive value of heart failure and death , but for the progress of heart failure severity change , changes in the measured value for sST2 correlation someone has not been confirmed.
- Conditions
- Stable Angina
- Being tested
- coronary angiography
- Keywords
- SYNTAX ,NGAL,Cystatin C,Galectin-3,Copeptin.MR-ProANP,sST2.
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary angiographyProcedure or surgery
percutaneous coronary intervention. coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| stable angina, biomarker | patients with stable angina who received coronary angiography. Receives: Procedure: coronary angiography | |
| placebo | healthy subject Receives: Procedure: coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker Titer of Patients With Coronary Artery Disease
The titer of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2).
Measured: 6-12 months
Biomarker of Healthy Subjects(Placebo)
The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) of healthy subjects(placebo).
Measured: 6-12 months
SYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram
The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) with SYNTAX score.
The SYNTAX Score is a unique tool to score complexity of coronary artery disease; there is no theoretical range existed for the SYNTAX score.
Low risk:<22; intermediate risk: 22-33, high risk:>33
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stable AnginaStudies 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
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yueh-Chung, Chen, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179047
- Sponsor's protocol ID
- TCHIRB-1030509-E
- Status last verified
- Apr 2017
- First submitted
- 27 May 2014
- Last updated
- 25 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlational Study on the Biomarkers Application to the Prediction and Diagnosis of Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT02179047
- Acronym / sponsor ID
- TCHIRB-1030509-E
- Conditions
- Stable Angina
- Keywords
- SYNTAX ,NGAL,Cystatin C,Galectin-3,Copeptin.MR-ProANP,sST2.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Posted 25 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through the literature review , we pick out a series of forward-looking biological indicators as follows :
- NGAL
- Cystatin C:
- Galectin-3:
- Copeptin:
- MR-Pro ANP:
- sST2:
Detailed description
- NGAL (Neutrophil Gelatinase Associated Lipocalin): in the cardiovascular system , NGAL and endothelial cell apoptosis , atherosclerosis , and abdominal aortic aneurysm associated with thrombosis of a relationship. Heart and kidney complications in common a number of studies have demonstrated that NGAL in acute heart failure , cardiac catheterization / angiography management, and diagnostic usefulness of acute coronary artery disease and heart surgery , and how to make NGAL may pathological processes in the cardiovascular play a role. In the past studies have also demonstrated in sepsis (sepsis), cardiopulmonary around to support cardiac surgery, caused by acute renal developer injury and renal transplant patients and other studies confirm this early detection of serum creatinine more acute kidney injury . So we tried to make the results in this study . (2) Cystatin C: Chronic kidney disease is a cardiovascular morbidity and mortality risk and a significant global health problem. Has been used to estimate renal function , serum creatinine, can be used instead . In several studies have shown to be more sensitive than that for predicting eGFRcreat serum creatinine or adverse events. This parameter also showed greater diagnostic sensitivity for the detection of mild renal damage . Cystatin C and metabolic syndrome and cardiovascular risk factors is also a correlation study confirmed (M. Magnusson et.al, 2013). Therefore , Cystatin C is emerging as a new biomarker for cardiovascular disease. (3) Galectin-3: has proven to be a marker of myocardial fibrosis, Lars Gullestad , who in 2012 also found that Galectin-3 is mainly predictive of ischemic etiology . elderly patients with systolic heart failure death. And approved by the U.S. Food and Drug Administration to help in the prognosis of patients with heart failure in 2011 . Research has also pointed out that , Galectin-3 and there is a positive correlation between renal injury , and the correlation is not affected by whether the patients suffering from heart failure while affected. (4) Copeptin: Copeptin was considered non -specific stress response of the marker , and may also have been proposed various non- cardiovascular monitoring and early warning and cardiovascular diseases ( coronary artery disease, heart failure and acute ) , etc., in a previous study , including patients with acute myocardial infarction was found with Copeptin related , and there Copeptin associated left ventricular ejection fraction (LVEF), and also the follow-up patients found to have a direct correlation with left ventricular volume, and is considered poor prognostic factor of death. (5) MR-Pro ANP (midregional-Pro atrial natriuretic peptide): discovery and diagnosis of heart failure can be predicted in 1984, is a major discovery in the field of biological indicators of heart , but also a milestone, Elif Elmas et al found that when the 2011 MR-Pro ANP in patients suffering from cardiovascular disease as a diagnosis of myocardial fibrosis new biological indicators. Past research has also pointed out that can be used to predict lower respiratory tract infections and pneumonia, long and short-term mortality, Alzheimer's disease, and can diagnose sepsis and bacterial shock and prognosis prediction . (6) sST2 (somatostatin2): Excessive sST2 may cause abnormal cardiac hypertrophy , fibrosis, and heart failure . Clinically, symptoms of heart failure with a high concentration of the patients diagnosed with sST2 severity determined correlations to predict increased risk of complications. Past research indicates measured values sST2 patients suffering from cardiovascular disease increased Jie phenomenon, and found that the measured values sST severity of cardiovascular disease 2 was positively correlated, has now been approved for use in patients with cardiovascular disease and new biomarkers predictive value of heart failure and death , but for the progress of heart failure severity change , changes in the measured value for sST2 correlation someone has not been confirmed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stable angina, biomarker | – | Procedure: coronary angiographypatients with stable angina who received coronary angiography. |
| placebo | – | Procedure: coronary angiographyhealthy subject |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with stable angina who received coronary angiography.
Key inclusion criteria (1 listed)
- stable angina who eligible for coronary angiography after non-invasive stress test.
Key exclusion criteria (1 listed)
- intolerance to procedure or contarst medium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary angiographypercutaneous coronary intervention. coronary angiography. | Procedure or surgery | placebo, stable angina, biomarker |
Primary outcome
Biomarker Titer of Patients With Coronary Artery Disease
Time frame: 6-12 months
The titer of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2).
Biomarker of Healthy Subjects(Placebo)
Time frame: 6-12 months
The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) of healthy subjects(placebo).
SYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram
Time frame: 6-12 months
The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) with SYNTAX score. The SYNTAX Score is a unique tool to score complexity of coronary artery disease; there is no theoretical range existed for the SYNTAX score. Low risk:<22; intermediate risk: 22-33, high risk:>33
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stable Angina, run by Taipei City Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 25 Feb 2020. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 25 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Biomarker Titer of Patients With Coronary Artery Disease (time frame: 6-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2020.