Velocity Vector Imaging in Patients With Moderate-to-Severe Aortic Regurgitation

NCT ID: NCT00624884

Last Updated: 2008-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Regurgitation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Aortic regurgitation,velocity vector imaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Patients with moderate-to-severe aortic regurgitation having normal left ventricular ejection fraction

No interventions assigned to this group

B

Age, sex and bodymass index matched healthy subjects

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Moderate-to-severe aortic regurgitation identified by Standard echocardiography.
* Chronic isolated aortic regurgitation
* Being asymptomatic ( Class 1 according to NYHA)
* Sinusal rhythm

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Florence Nightingale Hospital, Istanbul

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

T.C. Istanbul Bilim University, Florence Nightingale Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Saide Aytekin, Professor

Role: PRINCIPAL_INVESTIGATOR

T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

TC.Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology

Istanbul, Sisli, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17584200 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

YT1977

Identifier Type: -

Identifier Source: org_study_id