Clinical trial NCT00774657: Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography
Official title: Patterns Of Left Ventricular Remodeling In Patients With Aortic Stenosis Assessed By Two-Dimensional And Three-Dimensional Echocardiography
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Aortic Stenosis
Keywords: Aortic Stenosis
Valvular heart disease
Heart disease
Cardiovascular disease
Two dimensional echocardiography
Three dimensional echocardiography
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
Collaborators: name: Tufts Medical Center
First posted: 2008-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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

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 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

Primary outcomes:
measure: Evaluate 2-dimensional and 3-dimensional echocardiography for LV patterns of remodeling and hypertrophy
timeFrame: 1 hour
Secondary outcomes:
measure: Assess doppler diastolic filling indices for patterns of LV remodeling
timeFrame: 1 hour
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic, Inc.
state: Massachusetts
Study officials:
affiliation: Lahey Clinic, Inc.
name: Sherif B. Labib, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faggiano P, Rusconi C, Ghizzoni G, Sabatini T. Left ventricular remodeling and function in adult aortic stenosis. Angiology. 1994 Dec;45(12):1033-8. doi: 10.1177/000331979404501206.
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. doi: 10.1093/eurheartj/ehi290. Epub 2005 Apr 28.
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. doi: 10.3949/ccjm.56.6.590.
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. doi: 10.1016/j.jacc.2004.05.050.