Endostatin Serum Levels During Bicycle Stress Test

May 18, 2014 updated by: Jeanette Strametz-Juranek, Medical University of Vienna

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

Completed

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

200 patients, divided into sub-groups, always both genders will be tested for different conditions (smoking, age, CMP, CHD,...)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy young females
20 healthy females, aged between 18 and 35 years
Healthy young males
20 healthy males, aged between 18 and 35 years
Healthy elderly smokers
20 healthy smokers, aged between 45 and 75 years
Healthy elderly non-smokers
20 healthy non-smokers, aged between 45 and 75 years
Healthy young female smokers
20 healthy female smokers, aged between 18 and 35 years
Healthy young male smokers
20 healthy male smokers, aged between 18 and 35 years
Healthy postmenopausal women
20 healthy postmenopausal women
Female CMP Patients
20 female patients suffering from cardiomyopathy (ischemic or dilating)
Male CMP Patients
20 male patients suffering from cardiomyopathy (ischemic or dilating)
Female CHD patients
30 female patients suffering from cardiac heart disease, before aorto-coronary bypass surgery (and after)
Male CHD Patients
30 male patients suffering from cardiac heart disease, before aorto-coronary bypass surgery (and after)
male athlets
20 male athlets
female athlets
20 female athlets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endostatin
Time Frame: baseline/maximum
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
catecholamine
Time Frame: baseline
baseline sample will be drawn at rest
baseline
hemodynamic parameters
Time Frame: baseline
heart rate and blood pressure behavior will be monitored throughout the entire bicycle stress test
baseline
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeanette Strametz-Juranek, MD, MUV, Department of Internal Medicine II, Division of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 19, 2010

First Posted (Estimate)

July 20, 2010

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 18, 2014

Last Verified

May 1, 2014

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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