Brief Title
Risk Factors Associated With Calcification of the Aortic Valve
Official Title
Risk Markers of Coronary Artery Disease Associated With Calcific Aortic Valve Disease
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.
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.
Study Type
Observational
Condition
Aortic Stenosis
Study Arms / Comparison Groups
1
Description: Patients with aortic stenosis (mean transvalvular aortic gradient ≥30 mm Hg) plus angiographically significant coronary artery disease (more than 50% diameter stenosis)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
300
Start Date
January 2005
Completion Date
December 2008
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Katerina Linhartova, MD, PhD, ,
Location Countries
Czech Republic
Location Countries
Czech Republic
Administrative Informations
NCT ID
NCT00375336
Organization ID
IGA MH NR/8306-5
Study Sponsor
Charles University, Czech Republic
Study Sponsor
Katerina Linhartova, MD, PhD, Principal Investigator, Charles University of Prague, School of Medicine Pilsen, Czech Republic
Verification Date
December 2008