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Improving Echo Measurements in the Diagnosis of Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT02146755
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
Aortic stenosis is a common valvular heart disease, affecting mainly people over age 60. It is characterized by years to decades of slow progression followed by rapid clinical deterioration and a high death rate once symptoms develop. The onset of symptoms confers a poor prognosis: patients die within an average of five years after the onset of angina, three years after the onset of syncope, and two years after the onset of heart failure symptoms. The overall mortality rate is 75% at three years without surgery. Drug therapy for it remains ineffective, and aortic valve replacement is the only recommended long-term treatment.

Condition or disease
Aortic Valve Stenosis

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 396 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Improving The Quality Of Echocardiographic Imaging Measurements In The Diagnosis Of Severe Aortic Stenosis
Study Start Date : August 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Reclassification of patients based on CT measurements of LVOT for AVA and SVI. [ Time Frame: Baseline ]
    Echocardiography assessments of Aortic stenosis are technician dependent and can vary while CT evaluations are consistent and do not vary by user. This study will retrospectively examine subjects that have undergone both assessments as a workup for definitive aortic valve treatment. The anatomical measurements obtained from CT will be used to recalculate Aortic Valve Area utilizing the standard formulas and gradients/velocities obtained from echocardiography. Patients will be reclassified appropriately into "severe and non-severe" AS according to the new calculations. The results of this will be analyzed to establish standardized ranges for measurements to prevent over or under measuring aortic valve anatomy during these tests (Echo and CT).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is an observational, retrospective review of data collected as standard of care. The study intends to review the charts of up to 400 patients over the last 5 years who underwent both CT and TTE within a one-week timeframe as a workup for aortic valve stenosis at The Heart Hospital Baylor Plano (THHBP) or Baylor University Medical Center (BUMC).
Criteria

Inclusion Criteria

  • Adults over the age of 18.
  • Any patient undergoing both TTE and CT scans within a one-week timeframe as a workup for aortic stenosis.

Exclusion Criteria

  • There are no specific exclusion criteria for this retrospective review.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146755


Locations
United States, Texas
Baylor University Medical Center at Dallas
Dallas, Texas, United States, 75246
Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Paul Grayburn, MD Baylor Research Institute

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02146755     History of Changes
Other Study ID Numbers: 013-178
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction