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

Aortic Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624884
• Other study ID #: YT1977
• Status: Completed
• Phase: N/A
• First received: February 19, 2008
• Last updated: June 27, 2008
• Start date: March 2008
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: Florence Nightingale Hospital, Istanbul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health; Turkey: Ethics Committee
• Study type: Observational

Clinical 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 early operation which could be associated with operative risks and mortality related to prosthetic valves.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Valve Insufficiency

Locations

Country	Name	City	State
Turkey	TC.Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Florence Nightingale Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates		April 2008	No