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CompletedNCT01165515Updated May 20, 2014

Endostatin Serum Levels During Bicycle Stress Test

An observational study in Smoking and Cardiac Diseases, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-20.

Sponsored by Medical University of Vienna · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
240
Ages
18 Years to 75 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Smoking
  • Cardiac Diseases

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03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 240 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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,...)

Inclusion criteria

  • Smoking/Non smoking
  • Healthy/non healthy (if for CMP, CHD study)
  • Age (depending on the group affiliation)

Exclusion criteria

Exclusion Criteria:

  • Suffering from grave diseases
05

Study design

Time perspective
Prospective
Enrollment
240 participants (actual)

Groups and 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

06

What researchers measure

Primary outcomes

  1. Endostatin

    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)

    Time frame: baseline/maximum

Secondary outcomes

  1. catecholamine

    baseline sample will be drawn at rest

    Time frame: baseline

  2. hemodynamic parameters

    heart rate and blood pressure behavior will be monitored throughout the entire bicycle stress test

    Time frame: baseline

  3. catecholamine

    a second sample will be drawn 5 minutes after each individual reaches its peak workload (average time 10 minutes)

    Time frame: day 1

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Study locations

1 site
  • Medical University of Vienna
    Vienna, 1090, Austria
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References and documents

Publications

  • Sponder M, Dangl D, Kampf S, Fritzer-Szekeres M, Strametz-Juranek J. Exercise increases serum endostatin levels in female and male patients with diabetes and controls. Cardiovasc Diabetol. 2014 Jan 6;13:6. doi: 10.1186/1475-2840-13-6. PubMed 24393402 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01165515
Lead sponsor
Medical University of Vienna
Responsible party
Jeanette Strametz-Juranek (Ao.Univ.Prof.Dr, Medical University of Vienna) — Principal investigator
First posted
Jul 20, 2010
Start date
Jan 2008
Primary completion
Dec 2012
Completion
Apr 2013
Last update
May 20, 2014

Study contacts

Jeanette Strametz-Juranek, MD
principal investigator · MUV, Department of Internal Medicine II, Division of Cardiology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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