NCT01210157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
373

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
Last Updated

September 28, 2010

Status Verified

September 1, 2010

Enrollment Period

3 months

First QC Date

August 11, 2010

Last Update Submit

September 27, 2010

Conditions

Heart FailureCardiomyopathiesCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Death from cardiac causes

    up to five years

Secondary Outcomes (16)

  • diagnosis of coronary artery disease (CAD)

    up to five years

  • diagnosis of cardiomypathy (CMP)

    up to five years

  • assessment of disease stage (CAD-1-3, NYHA I-IV)

    up to five years

  • non-fatal myocardial infarction or cerebrovascular accident

    up to five years

  • revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG))

    up to five years

  • +11 more secondary outcomes

Study Arms (2)

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.)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing coronary angiography.

You may qualify if:

  • impaired ventricular function

You may not qualify if:

  • neoplastic disease
  • infections with hepatitis C or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg, Dept. of Cardiology

Heidelberg, 69120, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma

MeSH Terms

Conditions

Heart FailureCardiomyopathiesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Christian A Gleissner, MD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2010

First Posted

September 28, 2010

Study Start

June 1, 2008

Primary Completion

September 1, 2008

Study Completion

August 1, 2010

Last Updated

September 28, 2010

Record last verified: 2010-09

Locations

DE(1)