Cardio-Respiratory Health and Indoor Pollution

Cardiovascular Disease Clinical Trial

Official title:

Cardio-Respiratory Health in High Altitude Residents Exposed to Indoor Pollution

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01329159
• Other study ID #: HA indoor/pollution
• Status: Not yet recruiting
• Phase: N/A
• First received: April 1, 2011
• Last updated: April 4, 2011
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: March 2011
• Source: Università degli Studi di Ferrara
• Contact: Annalisa Cogo, MD
• Phone: +390532210420
• Email: cga[@]unife.it
• Is FDA regulated: No
• Health authority: Nepal: Health Research Council
• Study type: Observational

Clinical Trial Summary

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

1. the respiratory function decline by means of spirometry and the respiratory health by means of questionnaire and six-minute walking distance

2. 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

1. can accelerate the physiological respiratory function decline, usually around 15-20mL/year in healthy subjects

2. 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

3. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 80 Years

Eligibility

Inclusion Criteria:

• residents in the villages of the valley

Exclusion Criteria:

• under the age of 14

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Pulmonary Disease

Locations

Country	Name	City	State
Italy	Department of Clinical and Experimental Medicine- section of Respiratory Disease-University of Ferrara	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara	Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Country where clinical trial is conducted

Italy,