Left Ventricular Function GoodNCT01481415
Left Atrial Volume and Function in Children Assessed by Echo 3DRT: Reference Values for Normal Children
An observational study of Left Ventricular Function Good, run by Hospital Israelita Albert Einstein at 2 sites in Brazil.
Trial summary
The investigators study is trying to find the normal value to left atrial volume and left atrial function in healthy children by tridimensional real time echocardiography avaluation. Read more about this study
- Who is it for?
- Ages 3 months to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Ventricular Function Good
- How many people
- 145 participants
- Where
- 2 sitesBrazil
- Study dates
- Nov 2011to Dec 2012
- 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 3 months to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: community sample
Who may be able to join
- research murmur
Who cannot join
- any congenital heart disease
- any systemic disease
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital Israelita Albert Einstein
Sâo Paulo, Sao Pauo, 04613003
Laise Guimarães, MD, 55 11 2151 0429, laiseabg@einstein.br
Laise Guimarães
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 04613003
Laise Guimarães, MD, 55 11 21510429, laiseabg@einstein.br
About this study
Official title: Left Atrial Volume and Function in Healthy Children Assessed by Three Dimensional Echocardiography
The investigators study is trying to find the normal value to left atrial volume and left atrial function in healthy children by tridimensional real time echocardiography avaluation.
- Conditions
- Left Ventricular Function Good
- Keywords
- left atrial, three-dimensional echocardioraphy, left atrial function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2011
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Function GoodStudies 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
- Time perspective
- Retrospective
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Laise Antonia Bonfim Guimaraes, Hospital Israelita Albert Einstein
- Investigators
- Laise Antonia Bonfim Guimaraes, MD, Principal investigator, Sociedade Beneficente Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481415
- Sponsor's protocol ID
- p1
- Status last verified
- Dec 2011
- First submitted
- 25 Nov 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Volume and Function in Healthy Children Assessed by Three Dimensional Echocardiography
- ClinicalTrials.gov ID
- NCT01481415
- Acronym / sponsor ID
- p1
- Conditions
- Left Ventricular Function Good
- Keywords
- left atrial, three-dimensional echocardioraphy, left atrial function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Nov 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 29 Nov 2011 (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 investigators study is trying to find the normal value to left atrial volume and left atrial function in healthy children by tridimensional real time echocardiography avaluation.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 months to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- community sample
Key inclusion criteria (1 listed)
- research murmur
Key exclusion criteria (2 listed)
- any congenital heart disease
- any systemic disease
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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.
Laise Antonia Bonfim Guimaraes, MD principal investigator
Sociedade Beneficente Israelita Albert Einstein
2 sites 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 Good, run by Hospital Israelita Albert Einstein at 2 sites in Brazil.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laise Guimarães, MD (55 11 2141 0429, laiseabg@einsteinb.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 6 Dec 2011.