Risk Factors Associated With Calcification of the Aortic Valve

December 31, 2008 updated by: Charles University, Czech Republic

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Plzen, Czech Republic, 304060
        • Charles University of Prague, School of Medicine, Plzen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with aortic stenosis (mean transvalvular aortic gradient ≥30 mm Hg) plus angiographically significant coronary artery disease (more than 50% diameter stenosis)
2
Patients with nonobstructive aortic sclerosis (mean gradient ≤10 mmHg) plus angiographically significant coronary artery disease (more than 50% diameter stenosis)
3
Patients with normal aortic valve plus angiographically significant coronary artery disease (more than 50% diameter stenosis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

September 11, 2006

First Submitted That Met QC Criteria

September 11, 2006

First Posted (Estimate)

September 12, 2006

Study Record Updates

Last Update Posted (Estimate)

January 1, 2009

Last Update Submitted That Met QC Criteria

December 31, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGA MH NR/8306-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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