Galectin-3 Binding Protein in Cardiovascular Disease and Chronic Heart Failure

Coronary Artery Disease Clinical Trial

— GALACTIC  

Official title:

GALectin-3 Binding Protein for Risk Assessment in Coronary arTery dIsease and Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210157
• Other study ID #: GL_LGALS3BP
• Status: Completed
• Phase: N/A
• First received: August 11, 2010
• Last updated: September 27, 2010
• Start date: June 2008
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether galectin-3 binding protein plasma levels can predict adverse cardiovascular events in patients with coronary artery disease and/or heart failure.

Description:

Chronic heart failure represents an important cause of disease burden in Western countries. Heart failure can be either caused by vascular disease (i.e. cardiomypathy (CMP) due to coronary artery disease ("ischemic/ICMP")) or by myocardial conditions (i.e. dilated cardiomyopathies (DCMP) resulting from other causes like familial disposition, drug toxicity, etc.). Gold standard for the diagnosis of CMPs is the coronary angiography in conjunction with left ventricular angiography and myocardial biopsy, non-invasive markers include C-reactive protein (CRP) for ICMP and brain natriuretic protein (BNP) for DCMP. We have previously identified G3BP to be overexpressed in foam cells and plasma-derived microparticles, both potentially important in formation of atherosclerotic plaque. Galectin-3 binding protein (G3BP) is a secreted protein that is involved in cell adhesion and immune activation. The purpose of the current study is to test, whether G3BP plasma levels (a) are able to non-invasively differentiate causes of CMP and (b) are a suitable means for future risk assessment in CMP patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: August 2010
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• impaired ventricular function

Exclusion Criteria:

• neoplastic disease

• infections with hepatitis C or HIV

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiomyopathies
• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	University of Heidelberg, Dept. of Cardiology	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from cardiac causes		up to five years	No
Secondary	diagnosis of coronary artery disease (CAD)		up to five years	No
Secondary	diagnosis of cardiomypathy (CMP)		up to five years	No
Secondary	assessment of disease stage (CAD-1-3, NYHA I-IV)		up to five years	No
Secondary	non-fatal myocardial infarction or cerebrovascular accident		up to five years	No
Secondary	revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG))		up to five years	No
Secondary	rehospitalization		up to five years	No
Secondary	implantation of ICD/biventricular pacemaker		up to five years	No
Secondary	heart transplantation		up to five years	No
Secondary	correlation with patient history		up to five years	No
Secondary	correlation with physical examination		up to five years	No
Secondary	correlation with routine lab values		up to five years	No
Secondary	correlation with ECG		up to five years	No
Secondary	correlation with echocardiography		up to five years	No
Secondary	correlation with cardiac MRI		up to five years	No
Secondary	correlation with cardiac CT		up to five years	No
Secondary	correlation with chest X-ray		up to five years	No