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Reference Population for Speckle Tracking Imaging (STE Normal)

This study has been completed.
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation Identifier:
First received: January 31, 2012
Last updated: April 21, 2017
Last verified: April 2017
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.

Left Ventricular Function

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Establishment of normal values data in males and females aged 20 - 80 [ Time Frame: 1 year ]

Enrollment: 91
Study Start Date: December 2011
Study Completion Date: January 2015
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal healthy males and females

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
  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 identifier: NCT01526252

Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Principal Investigator: Terrence Ruddy, MD Ottawa Heart Institute Research Corporation
  More Information

Responsible Party: Terrence Ruddy, Principal Investigator, Ottawa Heart Institute Research Corporation Identifier: NCT01526252     History of Changes
Other Study ID Numbers: #2011803-01H
Study First Received: January 31, 2012
Last Updated: April 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Keywords provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:
speckle tracking echocardiography
database processed this record on August 18, 2017