Heart FailureGALACTICNCT01210157
Galectin-3 Binding Protein in Cardiovascular Disease and Chronic Heart Failure
An observational study of Heart Failure and Cardiomyopathies, run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Cardiomyopathies, Coronary Artery Disease
- How many people
- 373 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing coronary angiography.
Who may be able to join
- impaired ventricular function
Who cannot join
- neoplastic disease
- infections with hepatitis C or HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GALectin-3 Binding Protein for Risk Assessment in Coronary arTery dIsease and Chronic Heart Failure
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.
Read the 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.
- Conditions
- Heart Failure, Cardiomyopathies, Coronary Artery Disease
- Medical subject headings
- Heart Failure, Cardiomyopathies, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from cardiac causes
Measured: up to five years
Secondary outcomes (16)
diagnosis of coronary artery disease (CAD)
Measured: up to five years
diagnosis of cardiomypathy (CMP)
Measured: up to five years
assessment of disease stage (CAD-1-3, NYHA I-IV)
Measured: up to five years
non-fatal myocardial infarction or cerebrovascular accident
Measured: up to five years
revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG))
Measured: up to five years
rehospitalization
Measured: up to five years
implantation of ICD/biventricular pacemaker
Measured: up to five years
heart transplantation
Measured: up to five years
correlation with patient history
Measured: up to five years
correlation with physical examination
Measured: up to five years
correlation with routine lab values
Measured: up to five years
correlation with ECG
Measured: up to five years
correlation with echocardiography
Measured: up to five years
correlation with cardiac MRI
Measured: up to five years
correlation with cardiac CT
Measured: up to five years
correlation with chest X-ray
Measured: up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Christian A Gleissner, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210157
- Sponsor's protocol ID
- GL_LGALS3BP
- Acronym
- GALACTIC
- Status last verified
- Sep 2010
- First submitted
- 11 Aug 2010
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GALectin-3 Binding Protein for Risk Assessment in Coronary arTery dIsease and Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01210157
- Acronym / sponsor ID
- GALACTIC / GL_LGALS3BP
- Conditions
- Heart Failure, Cardiomyopathies, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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.) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing coronary angiography.
Key inclusion criteria (1 listed)
- impaired ventricular function
Key exclusion criteria (2 listed)
- neoplastic disease
- infections with hepatitis C or HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death from cardiac causes
Time frame: up to five years
16 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian A Gleissner, MD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiomyopathies, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from cardiac causes (time frame: up to five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2010.