Risk Factors Associated With Calcification of the Aortic Valve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Stenosis Aortic Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with aortic stenosis (mean transvalvular aortic gradient ≥30 mm Hg) plus angiographically significant coronary artery disease (more than 50% diameter stenosis)

No interventions assigned to this group

2

Patients with nonobstructive aortic sclerosis (mean gradient ≤10 mmHg) plus angiographically significant coronary artery disease (more than 50% diameter stenosis)

No interventions assigned to this group

3

Patients with normal aortic valve plus angiographically significant coronary artery disease (more than 50% diameter stenosis)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No