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
1 other identifier
observational
91
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
February 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedApril 24, 2017
April 1, 2017
7 months
January 31, 2012
April 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Establishment of normal values data in males and females aged 20 - 80
1 year
Eligibility Criteria
Normal healthy males and females
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Terrence Ruddy, MD
Ottawa Heart Institute Research Corporation
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 31, 2012
First Posted
February 3, 2012
Study Start
December 1, 2011
Primary Completion
July 1, 2012
Study Completion
January 1, 2015
Last Updated
April 24, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share
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.