Cardio-Respiratory Health and Indoor Pollution | NCT01329159

Studies
Cardio-Respiratory Health and Indoor Pollution

NCT01329159

Sponsor

Università degli Studi di Ferrara

Status

Unknown status

Last Update Posted

Apr 5, 2011Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Pulmonary Disease
Cardiovascular Disease

Interventions

Not provided

Countries

Italy

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

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Apr 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Apr 1, 2011

First Submission Date that Met QC Criteria

Apr 4, 2011

First Posted Date

Apr 5, 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

Apr 4, 2011

Last Update Posted Date

Apr 5, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Università degli Studi di FerraraOTHER

Collaborators

Name	Class
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy	OTHER_GOV

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 aim of this study is to assess in the sample of population resident in the KHUMBU valley (NEPAL):

the respiratory function decline by means of spirometry and the respiratory health by means of questionnaire and six-minute walking distance
the presence of markers of early atherosclerosis with ultrasound and to estimate the value of systolic pulmonary pressure in comparison with not exposed subjects.

The investigators hypothesize that the chronic exposure to indoor pollution

can accelerate the physiological respiratory function decline, usually around 15-20mL/year in healthy subjects
induce cardiovascular impairment

The population of high altitude villages is a unique sample to study the effect of the only indoor pollution. In fact, the absence of traffic, due to the lack of roads, and the very low level of smoking habits allow to have no other confounding factors
to study and analyze how the architectural features of the buildings of the village (distribution of domestic locals, natural or non natural ventilation systems, domestic activities, materials used, etc.) affect the indoor pollution from carbon monoxide, which necessarily is developed indoor during the daily life activities.

What the project prospects is to gather information focused on the scale of the building, independently from the typology, to study a model that will help to describe which aspects are most important to what concern the genesis of the pollution of the indoor air.

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

300Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

residents in the villages of the valley

Exclusion Criteria:

under the age of 14

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

residents in the Kumbu Valley (Nepal)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Annalisa Cogo, MD	Contact	+390532210420		cga@unife.it

Overall Officials

Name	Affiliation	Role
Annalisa Cogo, MD	University of Ferrara, Italy	Study Director
Lorenza Pratali, MD	Institute of Clinical Physiology National Council of Research, Pisa, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical and Experimental Medicine- section of Respiratory Disease-University of Ferrara		Ferrara	Ferrara	44100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases
D002318	Cardiovascular Diseases
D000532	Altitude Sickness
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided