Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography

Aortic Stenosis Clinical Trial

Official title:

Patterns Of Left Ventricular Remodeling In Patients With Aortic Stenosis Assessed By Two-Dimensional And Three-Dimensional Echocardiography

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00774657
• Other study ID #: 2008-090
• Status: Withdrawn
• Phase: N/A
• First received: October 16, 2008
• Last updated: February 16, 2012
• Start date: September 2008
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This preliminary study will compare the effectiveness of two-dimensional and three-dimensional echocardiographic measurements of wall thickness and left ventricular mass in patients with Aortic Stenosis

Description:

This study will evaluate left ventricular patterns of remodeling and hypertrophy in patients with aortic stenosis, and compare two-dimensional echocardiography measurements (wall thickness) with three-dimensional echocardiography data(left ventricular mass). Along with a second objective to assess Doppler diastolic filling indices associated with the various patterns of left ventricular remodeling.

Previous studies(see reference list) were primarily derived from two-dimensional echo data set(based on wall thickness). Various patterns of left ventricular remodeling have been described in response to increased pressure overload.

Three-dimensional echocardiography is a relatively new technique that is being increasingly used in the Echocardiography Lab in selected patients. This technique holds promise of being more accurate for volume-related measurements than the standard 2-dimensional echocardiography techniques.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects more than 18 yrs of age through 90 yrs of age

• Both male and female

• Patients with moderate or severe isolated Aortic Stenosis

• Patients who have been referred for both two-dimensional and three- dimensional echocardiographies.

Exclusion Criteria:

• Poor acoustic windows

• h/o CAD and wall motion abnormality

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Ventricular Remodeling

Locations

Country	Name	City	State
United States	Lahey Clinic, Inc.	Burlington	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Lahey Clinic	Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Faggiano P, Rusconi C, Ghizzoni G, Sabatini T. Left ventricular remodeling and function in adult aortic stenosis. Angiology. 1994 Dec;45(12):1033-8. — View Citation

Jenkins C, Bricknell K, Hanekom L, Marwick TH. Reproducibility and accuracy of echocardiographic measurements of left ventricular parameters using real-time three-dimensional echocardiography. J Am Coll Cardiol. 2004 Aug 18;44(4):878-86. — View Citation

Kupari M, Turto H, Lommi J. Left ventricular hypertrophy in aortic valve stenosis: preventive or promotive of systolic dysfunction and heart failure? Eur Heart J. 2005 Sep;26(17):1790-6. Epub 2005 Apr 28. — View Citation

Salcedo EE, Korzick DH, Currie PJ, Stewart WJ, Lever HM, Goormastic M. Determinants of left ventricular hypertrophy in patients with aortic stenosis. Cleve Clin J Med. 1989 Sep;56(6):590-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate 2-dimensional and 3-dimensional echocardiography for LV patterns of remodeling and hypertrophy		1 hour	No
Secondary	Assess doppler diastolic filling indices for patterns of LV remodeling		1 hour	No