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Completed

NCT Number: NCT02179047

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

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:

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Key information

Age range

20 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei City Hospital

Taipei, Taiwan

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • intolerance to procedure or contarst medium.

Treatment and study plan

Coronary Angiography

Procedure

percutaneous coronary intervention. coronary angiography.

Primary outcomes

  1. 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).

  2. 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).

  3. 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

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 1, 2014
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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