NCT05449912

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
982

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

July 5, 2022

Last Update Submit

February 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients registered in the RICO database

Patients hospitalized for myocardial infarction between 01/01/2002 and 31/12/2008

Other: Collection of environmental exposure data

Interventions

noise pollution air pollution proximity and accessibility to green spaces, blue spaces

Patients registered in the RICO database

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients registered in the RICO database

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (1)

  • Koczorowski M, Bernard N, Mauny F, Chague F, Pujol S, Maza M, Cottin Y, Zeller M; ENVI-MI Study Group. Environmental noise exposure is associated with atherothrombotic risk. Sci Rep. 2022 Feb 24;12(1):3151. doi: 10.1038/s41598-022-06825-0.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 8, 2022

Study Start

February 18, 2019

Primary Completion

February 28, 2020

Study Completion

December 31, 2020

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations