- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01165515
Endostatin Serum Levels During Bicycle Stress Test
Endostatin Serum Levels During Bicycle Stress Test in Different Samples
Endostatin, a 20-kDa cleavage product of collagen XVIII, is a component of the extracellular matrix expressed in the basement membrane. As a potent inhibitor of angiogenesis, endostatin induces endothelial cell apoptosis and diminishes cell migration, adhesion and proliferation.
Endostatin may stop the progression of atherosclerosis. Atherosclerotic heart disease involves unwanted tissue growth. By cutting off the blood supply from a plaque the likelihood of plaque rupture may eventually be reduced. Recent data indicates that the loss of collagen XVIII/endostatin is related to the enhancement of neo-vascularization and vascular permeability in atherosclerosis. Plaque neo-vascularization strongly correlates with the regional content of inflammatory cells. Furthermore, increased vascular permeability enhances lipid accumulation in the vessel walls, hence increasing foam cells.
Therapeutic angiogenesis is a most promising strategy for the treatment of myocardial infarction. However, it remains unknown if and how endogenous angiogenesis inhibitors, such as endostatin, regulate angiogenesis in myocardial infarction. Rat models showed that after myocardial infarction endostatin neutralization displayed adverse left ventricular remodeling and severe heart failure compared with controls. Although angiogenesis was increased, tissue remodeling and interstitial fibrosis were further exaggerated in post-myocardial infarction hearts by endostatin neutralization.
However, several studies suggest that endostatin may locally modulate coronary collateral formation by inhibiting collateral vessel formation in patients with ischemic heart disease.
During treadmill exercise tests in healthy volunteers a significant increase in circulating endostatin levels can be observed. Exercise induces angiogenesis in cardiac and skeletal muscles by decreasing endostatin in the muscle tissues to increase blood flow to these metabolically active tissues. Thereby endostatin is released into the general circulation.
In summary, endostatin might be a new weapon to fight against atherosclerotic progression by inhibiting neo-vascularization of atherosclerotic plaques.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Vienna, Austria, 1090
- Medical University of Vienna
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Smoking/Non smoking
- Healthy/non healthy (if for CMP, CHD study)
- Age (depending on the group affiliation)
Exclusion Criteria:
- Suffering from grave diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy young females
20 healthy females, aged between 18 and 35 years
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Healthy young males
20 healthy males, aged between 18 and 35 years
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Healthy elderly smokers
20 healthy smokers, aged between 45 and 75 years
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Healthy elderly non-smokers
20 healthy non-smokers, aged between 45 and 75 years
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Healthy young female smokers
20 healthy female smokers, aged between 18 and 35 years
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Healthy young male smokers
20 healthy male smokers, aged between 18 and 35 years
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Healthy postmenopausal women
20 healthy postmenopausal women
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Female CMP Patients
20 female patients suffering from cardiomyopathy (ischemic or dilating)
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Male CMP Patients
20 male patients suffering from cardiomyopathy (ischemic or dilating)
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Female CHD patients
30 female patients suffering from cardiac heart disease, before aorto-coronary bypass surgery (and after)
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Male CHD Patients
30 male patients suffering from cardiac heart disease, before aorto-coronary bypass surgery (and after)
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male athlets
20 male athlets
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female athlets
20 female athlets
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endostatin
Time Frame: baseline/maximum
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baseline sample will be drawn at rest; a second sample will be drawn 5 minutes after each individual reaches its peak workload (average time 10 minutes)
|
baseline/maximum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
catecholamine
Time Frame: baseline
|
baseline sample will be drawn at rest
|
baseline
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hemodynamic parameters
Time Frame: baseline
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heart rate and blood pressure behavior will be monitored throughout the entire bicycle stress test
|
baseline
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catecholamine
Time Frame: day 1
|
a second sample will be drawn 5 minutes after each individual reaches its peak workload (average time 10 minutes)
|
day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeanette Strametz-Juranek, MD, MUV, Department of Internal Medicine II, Division of Cardiology
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 220/2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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