Reference Population for Speckle Tracking Imaging

Left Ventricular Function Clinical Trial

— STE Normal  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526252
• Other study ID #: #2011803-01H
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: April 21, 2017
• Start date: December 2011
• Est. completion date: January 2015

Study information

• Verified date: April 2017
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 2015
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Left Ventricular Function

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of normal values data in males and females aged 20 - 80		1 year