Aortic StenosisNCT00375336
Risk Factors Associated With Calcification of the Aortic Valve
An observational study of Aortic Stenosis and Aortic Sclerosis, run by Charles University, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Aortic Sclerosis
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2005to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Charles University of Prague, School of Medicine, Plzen
Pilsen, 304060
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Stenosis, Aortic Sclerosis
- Keywords
- Aortic valve, Calcification, Endothelial dysfunction, Calcium metabolism, Coronary artery disease
- Medical subject headings
- Aortic Valve Stenosis, Calcinosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startJan 2005
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Investigators
- Katerina Linhartova, MD, PhD, Principal investigator, Charles University of Prague, School of Medicine Pilsen, Czech RepublicRoman Cerbak, Prof,MD,PhD, Study chair, Center for Cardiovascular and Transplantation Surgery, Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375336
- Sponsor's protocol ID
- IGA MH NR/8306-5
- Status last verified
- Dec 2008
- First submitted
- 11 Sep 2006
- Last updated
- 1 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17612911Ferda 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.
PubMed 17961946Linhartova 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.
PubMed 17186983Linhartova 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.
PubMed 18219161
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Markers of Coronary Artery Disease Associated With Calcific Aortic Valve Disease
- ClinicalTrials.gov ID
- NCT00375336
- Acronym / sponsor ID
- IGA MH NR/8306-5
- Conditions
- Aortic Stenosis, Aortic Sclerosis
- Keywords
- Aortic valve, Calcification, Endothelial dysfunction, Calcium metabolism, Coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Dec 2008 (estimated)
- First posted
- 12 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2009.
- Background: PubMed 17612911Linhartova 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.
- Background: PubMed 17961946Ferda 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.
- Background: PubMed 17186983Linhartova 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.
- Results publication: PubMed 18219161Linhartova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katerina Linhartova, MD, PhD principal investigator
Charles University of Prague, School of Medicine Pilsen, Czech Republic
Roman Cerbak, Prof,MD,PhD study chair
Center for Cardiovascular and Transplantation Surgery, Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Aortic Sclerosis, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00375336, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2009.