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Correlational Study on the Biomarkers Application to the Prediction and Diagnosis of Cardiovascular Diseases

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02179047
Enrollment
214
Registered
2014-07-01
Start date
2014-06-30
Completion date
2016-10-31
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Angina

Keywords

SYNTAX ,NGAL,Cystatin C,Galectin-3,Copeptin.MR-ProANP,sST2.

Brief 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:

Detailed description

1\) 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.

Interventions

PROCEDUREcoronary angiography

percutaneous coronary intervention. coronary angiography.

Sponsors

Taipei City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* stable angina who eligible for coronary angiography after non-invasive stress test.

Exclusion criteria

* intolerance to procedure or contarst medium.

Design outcomes

Primary

MeasureTime frameDescription
Biomarker Titer of Patients With Coronary Artery Disease6-12 monthsThe titer of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2).
Biomarker of Healthy Subjects(Placebo)6-12 monthsThe 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 Angiogram6-12 monthsThe 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

Countries

Taiwan

Participant flow

Participants by arm

ArmCount
Stable Angina
receive coronary angiogram
187
Placebo
healthy subjects
20
Total207

Baseline characteristics

CharacteristicPlaceboStable AnginaTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants50 Participants56 Participants
Age, Categorical
Between 18 and 65 years
14 Participants137 Participants151 Participants
Age, Continuous60 years
STANDARD_DEVIATION 12
62 years
STANDARD_DEVIATION 14
61 years
STANDARD_DEVIATION 13
Region of Enrollment
Taiwan
20 participants187 participants207 participants
Sex: Female, Male
Female
6 Participants50 Participants56 Participants
Sex: Female, Male
Male
14 Participants137 Participants151 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1870 / 20
other
Total, other adverse events
0 / 1870 / 20
serious
Total, serious adverse events
0 / 1870 / 20

Outcome results

Primary

Biomarker of Healthy Subjects(Placebo)

The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) of healthy subjects(placebo).

Time frame: 6-12 months

ArmMeasureValue (GEOMETRIC_MEAN)
NGALBiomarker of Healthy Subjects(Placebo)12 tilter
Cystatin CBiomarker of Healthy Subjects(Placebo)4 tilter
Galectin-3Biomarker of Healthy Subjects(Placebo)52 tilter
CopeptinBiomarker of Healthy Subjects(Placebo)0.1 tilter
MR-Pro ANPBiomarker of Healthy Subjects(Placebo)0.12 tilter
sST2Biomarker of Healthy Subjects(Placebo)121 tilter
p-value: 0.002ANOVA
Primary

Biomarker Titer of Patients With Coronary Artery Disease

The titer of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2).

Time frame: 6-12 months

ArmMeasureValue (GEOMETRIC_MEAN)
NGALBiomarker Titer of Patients With Coronary Artery Disease13 tilter
Cystatin CBiomarker Titer of Patients With Coronary Artery Disease5 tilter
Galectin-3Biomarker Titer of Patients With Coronary Artery Disease60 tilter
CopeptinBiomarker Titer of Patients With Coronary Artery Disease0.5 tilter
MR-Pro ANPBiomarker Titer of Patients With Coronary Artery Disease0.16 tilter
sST2Biomarker Titer of Patients With Coronary Artery Disease184 tilter
p-value: 0.002ANOVA
Primary

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

Time frame: 6-12 months

Population: The SYNTAX Score is a unique tool to score complexity of coronary artery disease; there is no theoretical range existed for the SYNTAX score.~SYNTAX Web site: http://www.syntaxscore.com/index.php Low risk:\<22; intermediate risk: 22-33, high risk:\>33

ArmMeasureValue (MEAN)Dispersion
NGALSYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram22 scores on a scaleStandard Deviation 8
Cystatin CSYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram19 scores on a scaleStandard Deviation 4
Galectin-3SYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram32 scores on a scaleStandard Deviation 8
CopeptinSYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram28 scores on a scaleStandard Deviation 13
MR-Pro ANPSYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram33 scores on a scaleStandard Deviation 15
sST2SYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram19 scores on a scaleStandard Deviation 3
Placebo(Healthy Subjects)SYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram6 scores on a scaleStandard Deviation 2
p-value: 0.001ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026