NCT00774657

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

3.4 years

First QC Date

October 16, 2008

Last Update Submit

February 16, 2012

Conditions

Keywords

Aortic StenosisValvular heart diseaseHeart diseaseCardiovascular diseaseTwo dimensional echocardiographyThree dimensional echocardiography

Outcome Measures

Primary Outcomes (1)

  • Evaluate 2-dimensional and 3-dimensional echocardiography for LV patterns of remodeling and hypertrophy

    1 hour

Secondary Outcomes (1)

  • Assess doppler diastolic filling indices for patterns of LV remodeling

    1 hour

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Poor acoustic windows
  • h/o CAD and wall motion abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Related 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. doi: 10.1177/000331979404501206.

    PMID: 7985830BACKGROUND
  • 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.

    PMID: 15860517BACKGROUND
  • 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.

    PMID: 2530009BACKGROUND
  • 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.

    PMID: 15312875BACKGROUND

MeSH Terms

Conditions

Aortic Valve StenosisHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseVentricular Outflow Obstruction

Study Officials

  • Sherif B. Labib, M.D.

    Lahey Clinic, Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

September 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations