Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 8:45 PM
Study NCT ID:
NCT01329159
Status:
UNKNOWN
Last Update Posted:
2011-04-05
First Post:
2011-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardio-Respiratory Health and Indoor Pollution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000532', 'term': 'Altitude Sickness'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-04', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-04-04', 'lastUpdatePostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High altitude', 'respiratory function', 'cardiorespiratory health', 'indoor pollution'], 'conditions': ['Pulmonary Disease', 'Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess in the sample of population resident in the KHUMBU valley (NEPAL):\n\n1. the respiratory function decline by means of spirometry and the respiratory health by means of questionnaire and six-minute walking distance\n2. the presence of markers of early atherosclerosis with ultrasound and to estimate the value of systolic pulmonary pressure in comparison with not exposed subjects.\n\nThe investigators hypothesize that the chronic exposure to indoor pollution\n\n1. can accelerate the physiological respiratory function decline, usually around 15-20mL/year in healthy subjects\n2. induce cardiovascular impairment\n\n 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\n3. 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.\n\nWhat 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'residents in the Kumbu Valley (Nepal)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residents in the villages of the valley\n\nExclusion Criteria:\n\n* under the age of 14'}, 'identificationModule': {'nctId': 'NCT01329159', 'briefTitle': 'Cardio-Respiratory Health and Indoor Pollution', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Ferrara'}, 'officialTitle': 'Cardio-Respiratory Health in High Altitude Residents Exposed to Indoor Pollution', 'orgStudyIdInfo': {'id': 'HA indoor/pollution'}}, 'contactsLocationsModule': {'locations': [{'zip': '44100', 'city': 'Ferrara', 'state': 'Ferrara', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Cogo, MD', 'role': 'CONTACT', 'email': 'cga@unife.it', 'phone': '+390532210420'}, {'name': 'Annalisa Cogo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Clinical and Experimental Medicine- section of Respiratory Disease-University of Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}], 'centralContacts': [{'name': 'Annalisa Cogo, MD', 'role': 'CONTACT', 'email': 'cga@unife.it', 'phone': '+390532210420'}], 'overallOfficials': [{'name': 'Annalisa Cogo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Ferrara, Italy'}, {'name': 'Lorenza Pratali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Clinical Physiology National Council of Research, Pisa, Italy'}, {'name': 'Luca Pomidori, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Ferrara'}, {'name': 'Sanjay Nath Khanal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kathmandu University'}, {'name': 'Enrico Duo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Ferrara'}, {'name': 'Maria Rosa Bruno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Clinical Physiology National Council of Research, Pisa, Italy'}, {'name': 'Chan Bahadur Thapa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tribhuvan University Institute of Medicine (Nepal)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Ferrara', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Annalisa Cogo', 'oldOrganization': 'University of Ferrara'}}}}