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Clinical Trials/NCT01526252
NCT01526252CompletedNot Applicable

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

Ottawa Heart Institute Research Corporation1 site in 1 country91 target enrollmentStarted: December 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
91
Locations
1
Primary Endpoint
Establishment of normal values data in males and females aged 20 - 80

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Establishment of normal values data in males and females aged 20 - 80

Time Frame: 1 year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Terrence Ruddy

Principal Investigator

Ottawa Heart Institute Research Corporation

Study Sites (1)

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