Left Ventricular FunctionSTE NormalNCT01526252
Reference Population for Speckle Tracking Imaging
An observational study of Left Ventricular Function, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Ventricular Function
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal healthy males and females
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Documented congenital heart conditions or defects
- History of diabetes
- Be unwilling to provide voluntary consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Left Ventricular Function
- Keywords
- speckle tracking echocardiography, database
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of normal values data in males and females aged 20 - 80
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terrence Ruddy, Ottawa Heart Institute Research Corporation
- Investigators
- Terrence Ruddy, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526252
- Sponsor's protocol ID
- #2011803-01H
- Acronym
- STE Normal
- Status last verified
- Apr 2017
- First submitted
- 31 Jan 2012
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01526252
- Acronym / sponsor ID
- STE Normal / #2011803-01H
- Conditions
- Left Ventricular Function
- Keywords
- speckle tracking echocardiography, database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal healthy males and females
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- Have taken cardioactive drugs within 6 months prior to examination
- Currently clinically significant chronic or acute illness
- Documented cardiovascular disease
- Possess abnormal cardiac structure and function after examination with routine ECHO
- Documented congenital heart conditions or defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establishment of normal values data in males and females aged 20 - 80
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrence Ruddy, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Function, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of normal values data in males and females aged 20 - 80 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017; AzTrials last refreshed its copy on 27 Oct 2026.