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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01210157
First Posted: September 28, 2010
Last Update Posted: September 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  Purpose
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.

Condition
Heart Failure Cardiomyopathies Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: GALectin-3 Binding Protein for Risk Assessment in Coronary arTery dIsease and Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Death from cardiac causes [ Time Frame: up to five years ]

Secondary Outcome Measures:
  • diagnosis of coronary artery disease (CAD) [ Time Frame: up to five years ]
  • diagnosis of cardiomypathy (CMP) [ Time Frame: up to five years ]
  • assessment of disease stage (CAD-1-3, NYHA I-IV) [ Time Frame: up to five years ]
  • non-fatal myocardial infarction or cerebrovascular accident [ Time Frame: up to five years ]
  • revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)) [ Time Frame: up to five years ]
  • rehospitalization [ Time Frame: up to five years ]
  • implantation of ICD/biventricular pacemaker [ Time Frame: up to five years ]
  • heart transplantation [ Time Frame: up to five years ]
  • correlation with patient history [ Time Frame: up to five years ]
  • correlation with physical examination [ Time Frame: up to five years ]
  • correlation with routine lab values [ Time Frame: up to five years ]
  • correlation with ECG [ Time Frame: up to five years ]
  • correlation with echocardiography [ Time Frame: up to five years ]
  • correlation with cardiac MRI [ Time Frame: up to five years ]
  • correlation with cardiac CT [ Time Frame: up to five years ]
  • correlation with chest X-ray [ Time Frame: up to five years ]

Biospecimen Retention:   Samples Without DNA
Serum, plasma

Enrollment: 373
Study Start Date: June 2008
Study Completion Date: August 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
I Ischemic CMP
Patients with impaired ventricular function caused by coronary artery disease.
II CMP
Patients with impaired ventricular function which is not caused by coronary artery disease. Subgroups based on etiology (familial cardiomyopathy, toxic cardiomyopathy, etc.)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing coronary angiography.
Criteria

Inclusion Criteria:

  • impaired ventricular function

Exclusion Criteria:

  • neoplastic disease
  • infections with hepatitis C or HIV
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210157


Locations
Germany
University of Heidelberg, Dept. of Cardiology
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Christian A Gleissner, MD Heidelberg University
  More Information

Responsible Party: Dr. Christian A. Gleissner, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01210157     History of Changes
Other Study ID Numbers: GL_LGALS3BP
First Submitted: August 11, 2010
First Posted: September 28, 2010
Last Update Posted: September 28, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases