Clinical trial NCT00375336: Risk Factors Associated With Calcification of the Aortic Valve
Official title: Risk Markers of Coronary Artery Disease Associated With Calcific Aortic Valve Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis
Aortic Sclerosis
Keywords: Aortic valve
Calcification
Endothelial dysfunction
Calcium metabolism
Coronary artery disease
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2006-09-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Plzen
country: Czech Republic
facility: Charles University of Prague, School of Medicine, Plzen
Study officials:
affiliation: Charles University of Prague, School of Medicine Pilsen, Czech Republic
name: Katerina Linhartova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Cardiovascular and Transplantation Surgery, Brno, Czech Republic
name: Roman Cerbak, Prof,MD,PhD
role: STUDY_CHAIR
References:
citation: Linhartova K, Filipovsky J, Cerbak R, Sterbakova G, Hanisova I, Beranek V. Severe aortic stenosis and its association with hypertension: analysis of clinical and echocardiographic parameters. Blood Press. 2007;16(2):122-8. doi: 10.1080/08037050701343241.
citation: Ferda J, Linhartova K, Kreuzberg B. Comparison of the aortic valve calcium content in the bicuspid and tricuspid stenotic aortic valve using non-enhanced 64-detector-row-computed tomography with prospective ECG-triggering. Eur J Radiol. 2008 Dec;68(3):471-5. doi: 10.1016/j.ejrad.2007.09.011. Epub 2007 Oct 24.
citation: Linhartova K, Beranek V, Sefrna F, Hanisova I, Sterbakova G, Peskova M. Aortic stenosis severity is not a risk factor for poststenotic dilatation of the ascending aorta. Circ J. 2007 Jan;71(1):84-8. doi: 10.1253/circj.71.84.
citation: Linhartova K, Veselka J, Sterbakova G, Racek J, Topolcan O, Cerbak R. Parathyroid hormone and vitamin D levels are independently associated with calcific aortic stenosis. Circ J. 2008 Feb;72(2):245-50. doi: 10.1253/circj.72.245.