Left Atrial Volume and Function in Children Assessed by E... | NCT01481415

Studies
Left Atrial Volume and Function in Children Assessed by Echo 3DRT: Reference Values for Normal Children

NCT01481415

Sponsor

Hospital Israelita Albert Einstein

Status

Unknown status

Last Update Posted

Dec 6, 2011Estimated

Enrollment

145Estimated

Phase

Not provided

Conditions

Left Ventricular Function Good

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2011Actual

Completion Date

Dec 2012Estimated

First Submitted Date

Nov 25, 2011

First Submission Date that Met QC Criteria

Nov 28, 2011

First Posted Date

Nov 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2011

Last Update Posted Date

Dec 6, 2011Estimated

Name	Class
University of Sao Paulo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

145Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

research murmur

Exclusion Criteria:

any congenital heart disease
any systemic disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

13 Years

Standard Ages

Child

Study Population

community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laise Guimarães, MD	Contact	55 11 2141 0429		laiseabg@einsteinb.br

Overall Officials

Name	Affiliation	Role
Laise Antonia Bonfim Guimaraes, MD	Sociedade Beneficente Israelita Albert Einstein	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Israelita Albert Einstein	Recruiting	Sâo Paulo	Sao Pauo	04613003	Brazil