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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05449912
Other study ID # Cottin Fondation Cœur 2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 18, 2019
Est. completion date December 31, 2020

Study information

Verified date July 2022
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Numerous studies have explored the effects of environmental exposure to noise, air pollution and proximity to "natural" areas on various conditions. However, very few studies have focused on the "post-diagnosis" follow-up of patients after hospitalization for an ischemic cardiovascular episode and, to our knowledge, none have examined patient evolution at one year after myocardial infarction. Thus, the real influence of factors and pollutants widely represented in the urban environment, in particular air pollution, noise pollution, and proximity and accessibility to natural areas ("green" or "blue" spaces), on the evolution of post-myocardial infarction at one year remains to be identified and quantified. The objective of the ENVI-MI project is to evaluate the impact of environmental exposure in the place of residence (noise, air pollution, proximity to "natural" spaces) on the evolution of post-myocardial infarction at one year within the Dijon metropolitan area.


Recruitment information / eligibility

Status Completed
Enrollment 982
Est. completion date December 31, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Patient : - registered in the RICO database - hospitalized for MI between January 1, 2002 and December 31, 2008, - whom residence is located in one of the 15 communes of the Dijon urban unit (except for patients living in the area subject to the noise exposure plan of the military airport) Exclusion Criteria: NA

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Collection of environmental exposure data
noise pollution air pollution proximity and accessibility to green spaces, blue spaces

Locations

Country Name City State
France Chu Dijon Bourogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of a cardiovascular event Occurrence of any of the following cardiovascular events during the 1-year follow-up: death, recurrence, or rehospitalization for CV causes 1 year
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