Risk Factors Associated With Calcification of the Aortic Valve

Aortic Stenosis Clinical Trial

Official title:

Risk Markers of Coronary Artery Disease Associated With Calcific Aortic Valve Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00375336
• Other study ID #: IGA MH NR/8306-5
• Status: Active, not recruiting
• Phase: N/A
• First received: September 11, 2006
• Last updated: December 31, 2008
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Sclerosis
• Aortic Stenosis
• Aortic Valve Stenosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Czech Republic	Charles University of Prague, School of Medicine, Plzen	Plzen

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

References & Publications (4)

Ferda J, Linhartová 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. Epub 2007 Oct 24. — View Citation

Linhartová K, Beránek V, Sefrna F, Hanisová I, Sterbáková G, Pesková M. Aortic stenosis severity is not a risk factor for poststenotic dilatation of the ascending aorta. Circ J. 2007 Jan;71(1):84-8. — View Citation

Linhartová K, Filipovský J, Cerbák R, Sterbáková G, Hanisová I, Beránek V. Severe aortic stenosis and its association with hypertension: analysis of clinical and echocardiographic parameters. Blood Press. 2007;16(2):122-8. — View Citation

Linhartová K, Veselka J, Sterbáková G, Racek J, Topolcan O, Cerbák R. Parathyroid hormone and vitamin D levels are independently associated with calcific aortic stenosis. Circ J. 2008 Feb;72(2):245-50. — View Citation