NCT01526252

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

January 31, 2012

Last Update Submit

April 21, 2017

Conditions

Keywords

speckle tracking echocardiographydatabase

Outcome Measures

Primary Outcomes (1)

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

    1 year

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Study Officials

  • Terrence Ruddy, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

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.

Locations