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Risk Factors Associated With Calcification of the Aortic Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00375336
Recruitment Status : Unknown
Verified December 2008 by Charles University, Czech Republic.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2006
Last Update Posted : January 1, 2009
Information provided by:
Charles University, Czech Republic

Brief Summary:

The purpose of this study is

  • to determine the degree of endothelial dysfunction and inflammation in calcific aortic valve disease associated with coronary artery disease(CAD).
  • to determine whether there is relationship between calcium metabolism and calcific aortic valve disease associated with CAD.

Condition or disease
Aortic Stenosis Aortic Sclerosis

Detailed Description:

Cardiovascular disease, mainly coronary artery disease, causes more than one half of deaths in the developed countries. Only recently, calcific aortic valve disease, was proved to belong to the family of atherosclerosis. It is associated with higher cardiovascular morbidity and mortality, the cause of which is not entirely clear. The link to significant coronary artery disease, probably, is of highest importance.

We compare groups of patients with coronary artery disease and calcific stenotic, sclerotic or intact aortic valve. The aim is to assess and compare their risk profile to verify our hypothesis that, within significant coronary artery disease, calcific aortic valve identifies a subgroup of patients with higher cardiovascular risk, assessed by endothelial dysfunction and the two year follow-up of cardiovascular events on optimally set treatment.

Further, we study the possible association of valvular calcification and calcium metabolism in patients with normal kidney function.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Markers of Coronary Artery Disease Associated With Calcific Aortic Valve Disease
Study Start Date : January 2005
Estimated Study Completion Date : December 2008

Patients with aortic stenosis (mean transvalvular aortic gradient ≥30 mm Hg) plus angiographically significant coronary artery disease (more than 50% diameter stenosis)
Patients with nonobstructive aortic sclerosis (mean gradient ≤10 mmHg) plus angiographically significant coronary artery disease (more than 50% diameter stenosis)
Patients with normal aortic valve plus angiographically significant coronary artery disease (more than 50% diameter stenosis)

Biospecimen Retention:   Samples Without DNA
serum and plasma specimens retained at -80 deg. C

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients admitted to hospital for evaluation due to common causes like dyspnea, chest pain, fatigue or syncope, who fulfilled the two inclusion criteria: 1/ angiographically significant CAD, and 2/ AS (mean transvalvular aortic gradient ≥30 mm Hg) or nonobstructive aortic sclerosis (mean gradient ≤10 mmHg) or had normal aortic valve as diagnosed by echocardiography.

Inclusion criteria:

  • significant stenosis (more than 50% diameter stenosis) of one or more coronary arteries
  • aortic sclerosis (group 1) or stenosis (AVA < 1cm2/m2, or mean gradient ≥ 30 mmHg) (group 2) or normal aortic valve (group 3)

Exclusion criteria:

  • Rheumatic heart disease (defined as aortic stenosis with commissural fusion + rheumatic mitral valve disease)
  • Status post aortic valve replacement
  • Congenital complex heart disease (except bicuspid aortic valve)
  • Moderate to severe aortic insufficiency (grade > 2/4)
  • Marfan syndrome
  • Infective endocarditis
  • Hypertrophic obstruction cardiomyopathy
  • Acute coronary syndrome within less than three months
  • Severe heart failure, NYHA class IV
  • Severe locomotion disability
  • Renal failure requiring dialysis
  • Significant systemic disease or other disease severely limiting the patient prognosis (e.g. known cancer, liver cirrhosis)
  • Primary hyperparathyroidism
  • Patient non-compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00375336

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Czech Republic
Charles University of Prague, School of Medicine, Plzen
Plzen, Czech Republic, 304060
Sponsors and Collaborators
Charles University, Czech Republic
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Principal Investigator: Katerina Linhartova, MD, PhD Charles University of Prague, School of Medicine Pilsen, Czech Republic
Study Chair: Roman Cerbak, Prof,MD,PhD Center for Cardiovascular and Transplantation Surgery, Brno, Czech Republic
Publications of Results:
Other Publications:
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Responsible Party: Ivana Ratajova, Charles University, School of Medicine Plzen Identifier: NCT00375336    
Other Study ID Numbers: IGA MH NR/8306-5
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: January 1, 2009
Last Verified: December 2008
Keywords provided by Charles University, Czech Republic:
Aortic valve
Endothelial dysfunction
Calcium metabolism
Coronary artery disease
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction