Aortic RegurgitationNCT00624884
Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation
An observational study of Aortic Regurgitation, run by Florence Nightingale Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
Velocity Vector Imaging may provide reliable and detailed information on left ventricular segmental function in asymptomatic patients with moderate-to severe AR. This may help to identify subclinical myocardial dysfunction in order to operate early enough to prevent postoperative heart failure and restrict unnecessary… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Regurgitation
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2008to May 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tertiary care clinic
Who may be able to join
- Moderate-to-severe aortic regurgitation identified by Standard echocardiography.
- Chronic isolated aortic regurgitation
- Being asymptomatic ( Class 1 according to NYHA)
- Sinusal rhythm
Who cannot join
- Ejection fraction < 50%
- Mitral valve disease accompanied to aortic regurgitation (patients with over mild degree of mitral regurgitation and stenosis
- Aortic stenosis
- Previous myocardial infarction, or the patients with >50% coronary occlusion in any of the coronary arteries.
- Cardiomyopathies
- AV conduction disorders
- Chronic renal or hepatic insufficiency
- Malignities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
TC.Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
Istanbul, Sisli, 34381
About this study
Velocity Vector Imaging may provide reliable and detailed information on left ventricular segmental function in asymptomatic patients with moderate-to severe AR. This may help to identify subclinical myocardial dysfunction in order to operate early enough to prevent postoperative heart failure and restrict unnecessary early operation which could be associated with operative risks and mortality related to prosthetic valves.
Read the detailed description
Chronic aortic regurgitation (AR) is a progressive process which causes both left ventricular volume and pressure overload. While the volume overload is associated with the degree of the aortic regurgitant volume, the pressure overload occurs as a result of systemic hypertension developed due to increased stroke volume. In early stages, excentric hypertrophy occurs aiming to compensate the volume overload in the left ventricle. Therefore , ejection fraction remains in normal range despite the increasing volume overload. Left ventricular dilatation and impairment in ejection fraction only occur in the end stages of the disease. Asymptomatic patients with chronic aortic regurgitation (AR) have a good prognosis in the presence of preserved systolic function. Therefore it is a challenge to identify patients with subclinical left ventricular (LV) dysfunction. Velocity vector imaging (VVI) is a new echocardiographic method based on two dimensional gray scale imaging, which is angle independent and can provide more accurate data about cardiac function.
- Conditions
- Aortic Regurgitation
- Keywords
- Aortic regurgitation,velocity vector imaging
- Medical subject headings
- Aortic Valve Insufficiency
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 |
|---|---|---|
| A | Patients with moderate-to-severe aortic regurgitation having normal left ventricular ejection fraction | |
| B | Age, sex and bodymass index matched healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates
Measured: April 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic RegurgitationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florence Nightingale Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Investigators
- Saide Aytekin, Professor, Principal investigator, T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624884
- Sponsor's protocol ID
- YT1977
- Status last verified
- Jun 2008
- First submitted
- 19 Feb 2008
- Last updated
- 30 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sokmen G, Sokmen A, Duzenli A, Soylu A, Ozdemir K. Assessment of myocardial velocities and global function of the left ventricle in asymptomatic patients with moderate-to-severe chronic aortic regurgitation: a tissue Doppler echocardiographic study. Echocardiography. 2007 Jul;24(6):609-14. doi: 10.1111/j.1540-8175.2007.00438.x.
PubMed 17584200
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation
- ClinicalTrials.gov ID
- NCT00624884
- Acronym / sponsor ID
- YT1977
- Conditions
- Aortic Regurgitation
- Keywords
- Aortic regurgitation,velocity vector imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Florence Nightingale Hospital, IstanbulUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 28 Feb 2008 (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.
Velocity Vector Imaging may provide reliable and detailed information on left ventricular segmental function in asymptomatic patients with moderate-to severe AR. This may help to identify subclinical myocardial dysfunction in order to operate early enough to prevent postoperative heart failure and restrict unnecessary early operation which could be associated with operative risks and mortality related to prosthetic valves.
Detailed description
Chronic aortic regurgitation (AR) is a progressive process which causes both left ventricular volume and pressure overload. While the volume overload is associated with the degree of the aortic regurgitant volume, the pressure overload occurs as a result of systemic hypertension developed due to increased stroke volume. In early stages, excentric hypertrophy occurs aiming to compensate the volume overload in the left ventricle. Therefore , ejection fraction remains in normal range despite the increasing volume overload. Left ventricular dilatation and impairment in ejection fraction only occur in the end stages of the disease. Asymptomatic patients with chronic aortic regurgitation (AR) have a good prognosis in the presence of preserved systolic function. Therefore it is a challenge to identify patients with subclinical left ventricular (LV) dysfunction. Velocity vector imaging (VVI) is a new echocardiographic method based on two dimensional gray scale imaging, which is angle independent and can provide more accurate data about cardiac function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Patients with moderate-to-severe aortic regurgitation having normal left ventricular ejection fraction |
| B | – | –Age, sex and bodymass index matched healthy subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care clinic
Key inclusion criteria (4 listed)
- Moderate-to-severe aortic regurgitation identified by Standard echocardiography.
- Chronic isolated aortic regurgitation
- Being asymptomatic ( Class 1 according to NYHA)
- Sinusal rhythm
Key exclusion criteria (8 listed)
- Ejection fraction < 50%
- Mitral valve disease accompanied to aortic regurgitation (patients with over mild degree of mitral regurgitation and stenosis
- Aortic stenosis
- Previous myocardial infarction, or the patients with >50% coronary occlusion in any of the coronary arteries.
- Cardiomyopathies
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
Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates
Time frame: April 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2008.
- Background: PubMed 17584200Sokmen G, Sokmen A, Duzenli A, Soylu A, Ozdemir K. Assessment of myocardial velocities and global function of the left ventricle in asymptomatic patients with moderate-to-severe chronic aortic regurgitation: a tissue Doppler echocardiographic study. Echocardiography. 2007 Jul;24(6):609-14. doi: 10.1111/j.1540-8175.2007.00438.x.
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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.
Saide Aytekin, Professor principal investigator
T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
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 Regurgitation, run by Florence Nightingale Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 30 Jun 2008. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates (time frame: April 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00624884, which also lists 1 linked publication.
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 30 Jun 2008.