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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Constriction, Pathologic
Aortic Valve Stenosis
Ventricular Remodeling
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 18, 2014