Reference Population for Speckle Tracking Imaging (STE Normal)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT01526252
First received: January 31, 2012
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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.


Condition
Left Ventricular Function

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Establishment of normal values data in males and females aged 20 - 80 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal healthy males and females

Criteria

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 ClinicalTrials.gov identifier: NCT01526252

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

No publications provided

Responsible Party: Terrence Ruddy, Principal Investigator, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01526252     History of Changes
Other Study ID Numbers: #2011803-01H
Study First Received: January 31, 2012
Last Updated: October 7, 2014
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Heart Institute Research Corporation:
speckle tracking echocardiography
database

ClinicalTrials.gov processed this record on October 19, 2014