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Endostatin Serum Levels During Bicycle Stress Test

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeanette Strametz-Juranek, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01165515
First received: July 13, 2010
Last updated: May 18, 2014
Last verified: May 2014
  Purpose

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.


Condition
Smoking
Cardiac Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Endostatin Serum Levels During Bicycle Stress Test in Different Samples

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Endostatin [ Time Frame: baseline/maximum ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • catecholamine [ Time Frame: baseline ] [ Designated as safety issue: No ]
    baseline sample will be drawn at rest

  • hemodynamic parameters [ Time Frame: baseline ] [ Designated as safety issue: No ]
    heart rate and blood pressure behavior will be monitored throughout the entire bicycle stress test

  • catecholamine [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    a second sample will be drawn 5 minutes after each individual reaches its peak workload (average time 10 minutes)


Enrollment: 240
Study Start Date: January 2008
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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,...)

Criteria

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
  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: NCT01165515

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Jeanette Strametz-Juranek, MD MUV, Department of Internal Medicine II, Division of Cardiology
  More Information

Publications:
Responsible Party: Jeanette Strametz-Juranek, Ao.Univ.Prof.Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01165515     History of Changes
Other Study ID Numbers: 220/2007
Study First Received: July 13, 2010
Last Updated: May 18, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014