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Risk Factors Associated With Calcification of the Aortic Valve

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Charles University, Czech Republic.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00375336
First received: September 11, 2006
Last updated: December 31, 2008
Last verified: December 2008
History of Changes
  Purpose

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.

Condition
Aortic Stenosis
Aortic Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Markers of Coronary Artery Disease Associated With Calcific Aortic Valve Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charles University, Czech Republic:

Biospecimen Retention:   Samples Without DNA

serum and plasma specimens retained at -80 deg. C


Estimated Enrollment: 300
Study Start Date: January 2005
Estimated Study Completion Date: December 2008
Groups/Cohorts
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375336

Locations
Czech Republic
Charles University of Prague, School of Medicine, Plzen
Plzen, Czech Republic, 304060
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Ivana Ratajova, Charles University, School of Medicine Plzen
ClinicalTrials.gov Identifier: NCT00375336     History of Changes
Other Study ID Numbers: IGA MH NR/8306-5
Study First Received: September 11, 2006
Last Updated: December 31, 2008
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Charles University, Czech Republic:
Aortic valve
Calcification
Endothelial dysfunction
Calcium metabolism
Coronary artery disease

Additional relevant MeSH terms:
Aortic Valve Stenosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Sclerosis
Arteriosclerosis
Aortic Diseases
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013