NCT03385122

Brief Summary

Environmental factors constitute an important but underappreciated risk factor towards the development and progression of cardiovascular disease (CVD). Environmental exposure in variable pollutants is implicated in the derangement or propagation of adverse pathophysiological processes linked with atherosclerosis, including genetic, hemodynamic, metabolic, oxidative and inflammation parameters. However no data exists concerning environmental pollution in rural or semi-rural areas. Therefore the purpose of the "Corinthia" study is to examine the impact of environmental pollution in indices of cardiovascular morbidity and mortality in a cross-sectional and longitudinal design. Corinthia study began in October 2015 and is planned to recruit 2400 individuals from different regions of Corinthia country with different environmental exposure to pollutants and different patterns of soil-ground and/or air pollution until September 2018. Baseline measurements will include lifestyle measurements, anthropometric characteristics and a comprehensive cardiovascular examination. The follow-up is planned to extent, prospectively, up to 10 years and this study is anticipated to provide valuable data on the distinct impact of soil and air pollution in early markers of atherosclerosis and cardiovascular disease and in the overall impact of environment pollution to cardiovascular morbidity and mortality.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress70%
Oct 2015Dec 2030

Study Start

First participant enrolled

October 20, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
12.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

2.9 years

First QC Date

November 20, 2017

Last Update Submit

December 26, 2017

Conditions

Keywords

Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

    Cardiovascular death, non fatal acute myocardial infarction, non fatal stroke

    15 Years

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We plan to recruit individuals living in three different areas according to environmental pollution i. Subjects living in areas with no evidence of soil/ground or air pollution ii. Subjects living in areas with air pollution iii. Subjects living in areas with soil/ground pollution

You may qualify if:

  • Inhabitants of Corinthia Region

You may not qualify if:

  • Inability and unwillingness to obtain informed consent
  • Individuals less than 40 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1st Cardiology Department, Hippokration General Hospital

Athens, Attica, 11528, Greece

RECRUITING

Hippokration Hospital, First Cardiology Clinic

Athens, 11528, Greece

RECRUITING

Related Publications (1)

  • Oikonomou E, Lazaros G, Georgiopoulos G, Christoforatou E, Papamikroulis GA, Vogiatzi G, Chasikidis C, Zacharia E, Giannaki A, Bourouki E, Mavratzas T, Stofa E, Papakonstantinou M, Tousouli M, Tousoulis D. Environment and cardiovascular disease: rationale of the Corinthia study. Hellenic J Cardiol. 2016 May-Jun;57(3):194-197. doi: 10.1016/j.hjc.2016.06.001. Epub 2016 Jun 23.

    PMID: 27451913BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Dimitris Tousoulis

    National and Kapodistrian University of Athens, Greece, First Cardiology Clinic, Hippokratio Hospital

    STUDY CHAIR

Central Study Contacts

Evangelos Oikonomou

CONTACT

Dimitris Tousoulis

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 28, 2017

Study Start

October 20, 2015

Primary Completion

September 30, 2018

Study Completion (Estimated)

December 31, 2030

Last Updated

December 28, 2017

Record last verified: 2017-12

Locations