Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography

This study has been withdrawn prior to enrollment.

(Unable to identify and recruit suitable study subjects)

Sponsor:

Collaborator:

Tufts Medical Center

Information provided by (Responsible Party):

Lahey Clinic

ClinicalTrials.gov Identifier:

NCT00774657

First received: October 16, 2008

Last updated: February 16, 2012

Last verified: February 2012

History of Changes

Purpose

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

Condition
Aortic Stenosis

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Patterns Of Left Ventricular Remodeling In Patients With Aortic Stenosis Assessed By Two-Dimensional And Three-Dimensional Echocardiography

Resource links provided by NLM:

Genetics Home Reference related topics: supravalvular aortic stenosis

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:

Evaluate 2-dimensional and 3-dimensional echocardiography for LV patterns of remodeling and hypertrophy [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess doppler diastolic filling indices for patterns of LV remodeling [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	September 2008
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Lahey Clinic patients who have been referred to the echocardiography lab for clinical indications, found to have a aortic stenosis

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774657

Locations

United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805

Sponsors and Collaborators

Lahey Clinic

Tufts Medical Center

Investigators

Principal Investigator:

Sherif B. Labib, M.D.

Lahey Clinic, Inc.

More Information

Publications:

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

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.

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.

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.

Responsible Party:	Lahey Clinic
ClinicalTrials.gov Identifier:	NCT00774657 History of Changes
Other Study ID Numbers:	2008-090
Study First Received:	October 16, 2008
Last Updated:	February 16, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Lahey Clinic:

Aortic Stenosis
Valvular heart disease
Heart disease

Cardiovascular disease
Two dimensional echocardiography
Three dimensional echocardiography

Additional relevant MeSH terms:

Aortic Valve Stenosis
Constriction, Pathologic
Ventricular Remodeling
Heart Valve Diseases

Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013

To Top