Acute Exposure to Diesel: Prolong Effects on Inflammation and Vasculature
DEVA
1 other identifier
interventional
40
1 country
2
Brief Summary
Cross-over double-blind study. Healthy subjects will be exposed to diesel exhaust fumes and/or filtered air during a 2-hour session. Several parameters will be assesed i.e. endothelial function will be assessed with flow mediated dilation (FMD) techniques, arterial stiffness with pulse wave velocity (PWV) and reflected waves with augmentation index (AIx). C reactive protein (CRP), fibrinogen, protein C levels and protein S activity will be also measured. Heart rate variability and standard deviation of normal to normal intervals R-R intervals (SDNN) will be used to assess sympathetic activity. Measurements were assessed before, 2 and 24 hours after diesel exposure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 15, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedSeptember 24, 2019
September 1, 2019
10 years
September 15, 2019
September 21, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Endothelial function assesment
The following outcome will be evaluated Changes over time of : Flow mediated dilation (FMD) mesured in the branchial artery with ultrasound. Units %
24 hours
Arterial Stifness
The following outcome will be evaluated Changes over time of : Carotid-femoral pulse wave velocity (PWV), measured non invasively Units: m/sec
24 hours
Secondary Outcomes (2)
Sympathetid Activity
24 hours
Inflammation
24 hours
Study Arms (2)
Diesel Exposure
EXPERIMENTALFiltered Air Exposure
PLACEBO COMPARATORInterventions
Exposure to diesel exhaust fumes
Eligibility Criteria
You may qualify if:
- Healthy subjects
You may not qualify if:
- Chronic diseases Cardiovascular diseases Respiratory diseases Pregnacy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
1st Cardiology Department, Hippokration General Hospital
Athens, Attica, 11528, Greece
Evangelos Oikonomou
Athens, Please Select, 17122, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blind
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Dimitris Tousoulis
Study Record Dates
First Submitted
September 15, 2019
First Posted
September 23, 2019
Study Start
January 1, 2015
Primary Completion
December 31, 2024
Study Completion (Estimated)
December 31, 2026
Last Updated
September 24, 2019
Record last verified: 2019-09