Improving Echo Measurements in the Diagnosis of Aortic Stenosis

NCT02146755 | Completed

• 1 other identifier: 013-178
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 2

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Reclassification of patients based on CT measurements of LVOT for AVA and SVI.

  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).

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (2)

Baylor University Medical Center at Dallas

Dallas, Texas, 75246, United States

Location

Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Paul Grayburn, MD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: May 26, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)