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

February 21, 2020 updated by: Yueh-Chung, Chen, Taipei City Hospital

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:

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with stable angina who received coronary angiography.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • intolerance to procedure or contarst medium.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
stable angina, biomarker
patients with stable angina who received coronary angiography.
Procedure: coronary angiography
percutaneous coronary intervention. coronary angiography.
placebo
healthy subject
Procedure: coronary angiography
percutaneous coronary intervention. coronary angiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6-12 months
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).
6-12 months
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
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCHIRB-1030509-E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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