NCT00624884

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 30, 2008

Status Verified

June 1, 2008

Enrollment Period

1 month

First QC Date

February 19, 2008

Last Update Submit

June 27, 2008

Conditions

Keywords

Aortic regurgitation,velocity vector imaging

Outcome Measures

Primary Outcomes (1)

  • Velocity Vector Imaging derived segmental systolic peak Strain and Strain rates

    April 2008

Study Arms (2)

A

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

B

Age, sex and bodymass index matched healthy subjects

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Tertiary care clinic

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, Sisli, 34381, Turkey (Türkiye)

Location

Related 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. doi: 10.1111/j.1540-8175.2007.00438.x.

    PMID: 17584200BACKGROUND

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Saide Aytekin, Professor

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

March 1, 2008

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

June 30, 2008

Record last verified: 2008-06

Locations