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

Stable Angina Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179047
• Other study ID #: TCHIRB-1030509-E
• Status: Completed
• Start date: June 2014
• Est. completion date: October 2016

Study information

• Verified date: April 2017
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 95 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• intolerance to procedure or contarst medium.

Related Conditions & MeSH terms

• Angina, Stable
• Stable Angina

Intervention

Procedure:
• coronary angiography
percutaneous coronary intervention. coronary angiography.

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker Titer of Patients With Coronary Artery Disease	The titer of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2).	6-12 months
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).	6-12 months
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	6-12 months