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

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01210157
First received: August 11, 2010
Last updated: September 27, 2010
Last verified: September 2010
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diagnosis of coronary artery disease (CAD) [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • diagnosis of cardiomypathy (CMP) [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • assessment of disease stage (CAD-1-3, NYHA I-IV) [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • non-fatal myocardial infarction or cerebrovascular accident [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)) [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • rehospitalization [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • implantation of ICD/biventricular pacemaker [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • heart transplantation [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • correlation with patient history [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • correlation with physical examination [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • correlation with routine lab values [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • correlation with ECG [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • correlation with echocardiography [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • correlation with cardiac MRI [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • correlation with cardiac CT [ Time Frame: up to five years ] [ Designated as safety issue: No ]
  • correlation with chest X-ray [ Time Frame: up to five years ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Christian A. Gleissner, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01210157     History of Changes
Other Study ID Numbers: GL_LGALS3BP
Study First Received: August 11, 2010
Last Updated: September 27, 2010
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 22, 2014