Left Atrial Volume and Function Evaluation in Patients Wi... | NCT00570115

Studies
Left Atrial Volume and Function Evaluation in Patients With Obstructive Sleep Apnea

NCT00570115

Sponsor

Associação Fundo de Incentivo à Pesquisa

Status

Completed

Last Update Posted

May 8, 2012Estimated

Enrollment

106Actual

Phase

Not provided

Conditions

Sleep Apnea Syndromes

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 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Not provided

Completion Date

Nov 2007Actual

First Submitted Date

Dec 7, 2007

First Submission Date that Met QC Criteria

Dec 7, 2007

First Posted Date

Dec 10, 2007Estimated

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

May 7, 2012

Last Update Posted Date

May 8, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left atrial morphology and function evaluated by echocardiography three dimensional

Detailed Description

Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function . It may lead to atrial myocardium stretching and enlargement which may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional LA changes might be found using three dimensional echo, and that such alterations are related to obstructive sleep apnea presence.

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

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		The subjects for this group are matched for age, gender, body mass index. The presence of obstructive sleep apnea will divide the cohort in 02 subgroups: non-Obstructive Sleep Apnea and Obstructive Sleep Apnea

Interventions

Not provided

Measure	Description	Time Frame
Left Atrial enlargement		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age from 30 to 70
Apnea-hypopnea index > 5 by polysomnography

Exclusion Criteria:

Any cardiac disease
Poor imaging quality by mean of echocardiography
non-sinusal Rhythm

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

The investigators recruited 56 recently diagnosed OSA patients, confirmed by full polysomnography (PSG), referred to Sleep Laboratory of Psychobiology Department of Federal University of Sao Paulo, Brazil, according to the following inclusion criteria: both genders aging from 29 to 70 years old, with apnea-hypopnea index (AHI) >5 events/hour of sleep. Control group comprised 50 healthy community subjects without OSA confirmed by full PSG, matched by age, gender, and BMI.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sergio Tufik, PhD,MD.	Federal University of São Paulo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto do Sono/Federal University of Sao Paulo		São Paulo	São Paulo	04020060	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17442422	Background	Anwar AM, Soliman OI, Geleijnse ML, Nemes A, Vletter WB, ten Cate FJ. Assessment of left atrial volume and function by real-time three-dimensional echocardiography. Int J Cardiol. 2008 Jan 11;123(2):155-61. doi: 10.1016/j.ijcard.2006.12.017. Epub 2007 Apr 17.

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic