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This study has been withdrawn prior to enrollment.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
  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:


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:
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 April 16, 2014