Clinical trial NCT01210157: Galectin-3 Binding Protein in Cardiovascular Disease and Chronic Heart Failure
Official title: GALectin-3 Binding Protein for Risk Assessment in Coronary arTery dIsease and Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cardiomyopathies
Coronary Artery Disease
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 373
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing coronary angiography.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* impaired ventricular function

Exclusion Criteria:

* neoplastic disease
* infections with hepatitis C or HIV

Primary outcomes:
measure: Death from cardiac causes
timeFrame: up to five years
Secondary outcomes:
measure: diagnosis of coronary artery disease (CAD)
timeFrame: up to five years
measure: diagnosis of cardiomypathy (CMP)
timeFrame: up to five years
measure: assessment of disease stage (CAD-1-3, NYHA I-IV)
timeFrame: up to five years
measure: non-fatal myocardial infarction or cerebrovascular accident
timeFrame: up to five years
measure: revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG))
timeFrame: up to five years
measure: rehospitalization
timeFrame: up to five years
measure: implantation of ICD/biventricular pacemaker
timeFrame: up to five years
measure: heart transplantation
timeFrame: up to five years
measure: correlation with patient history
timeFrame: up to five years
measure: correlation with physical examination
timeFrame: up to five years
measure: correlation with routine lab values
timeFrame: up to five years
measure: correlation with ECG
timeFrame: up to five years
measure: correlation with echocardiography
timeFrame: up to five years
measure: correlation with cardiac MRI
timeFrame: up to five years
measure: correlation with cardiac CT
timeFrame: up to five years
measure: correlation with chest X-ray
timeFrame: up to five years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg, Dept. of Cardiology
Study officials:
affiliation: Heidelberg University
name: Christian A Gleissner, MD
role: PRINCIPAL_INVESTIGATOR
References: