Reference Population for Speckle Tracking Imaging (STE Normal)

Establishing a Reference Population for Normal Left Ventricular Function Parameters to Validate the Use of Two Dimensional Speckle Tracking Imaging Software in the Scar Study

The SCAR study uses a software program entitled QLAB, a proprietory program, developed by Philips Healthcare (Philips Healthcare, Andover, MA). Literature on two-dimensional speckle tracking imaging (2DSTE) is growing, but data relevant to the population in the SCAR study is minimal. Accumulation of data relevant for a population of subjects will provide a set of normal values for interpretation of 2DSTE and minimize any influences from differences in data produced from different companies. This data may also assist other researchers investigate other cardiac diseases and abnormalities.

Study Overview

• Status: Completed
• Conditions: Left Ventricular Function

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal healthy males and females

Description

Inclusion Criteria:

• Be between the ages of 20 - 80 years at study entry
• Provide written informed consent and be able to comply with study procedures, including permission to access medical records
• Have a BMI index equal to or less than 35
• Less than 5% risk of developing coronary artery disease as determined using the Combined Diamond/Forrester and CASS data (ACC Stable CAD Guidelines)

Exclusion Criteria:

• Have taken cardioactive drugs within 6 months prior to examination

  • These include but are not limited to beta-blockers, calcium channel blockers, and angiotensin converting enzyme inhibitors
• Currently clinically significant chronic or acute illness
• Documented cardiovascular disease

• Possess abnormal cardiac structure and function after examination with routine ECHO

  • This may include valvular defects, left ventricular hypertrophy, cardiomyopathies or pericardial disease
• Documented congenital heart conditions or defects
• History of diabetes
• Be unwilling to provide voluntary consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Establishment of normal values data in males and females aged 20 - 80	1 year

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Terrence Ruddy, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: database; speckle tracking echocardiography
• Other Study ID Numbers: #2011803-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The objective of the trial was to establish a normal database for comparison. The database has not produced a specific study result. There is no publication as the sample size was not adequate.