The North Kynouria Project

October 30, 2023 updated by: Liontos Angelos, University Hospital, Ioannina

Mass Screening of the Population of the North Kynouria Municipality in Arcadia, Greece for the Detection of Cardiovascular and Stroke Risk Factors

The North Kynouria Project was initiated to study cardiovascular/stroke risk factors by employing mass screening and long-term surveillance of an adult population in the municipality of North Kynouria, in the county of Arcadia, Peloponnese, Greece. The North Kynouria Study was initiated to assess modifiable and non-modifiable determinants of cerebrovascular and coronary heart disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

The North Kynouria Project is a longitudinal, interventional-behavioural, prospective study aiming to identify cardiovascular/stroke risk factors, in the adult population of the municipality of North Kynouria, in the county of Arcadia, Peloponnese, Greece. The project, initiated in November 2022, recruits volunteers, of both sexes, over 18 years of age, irrespective of their personal history of cardiovascular disease. The epidemiology and burden of cardiovascular disease in North Kynouria remain unknown. The study aims to explore and document the prevalence of major cardiovascular/stroke risk factors, as well as the nutritional status, cigarette smoking, exercise habits, alcohol consumption, and overall quality of life of the inhabitants.

DESIGN NARRATIVE:

The screening exam is conducted at the Astros, Health Center, by obtaining the patient's personal history, and information about the patient's habits, such as physical activity, smoking, and alcohol consumption. Body weight, height, and waist-to-hip ratio are also measured. During the examination, blood pressure is evaluated using a pre-specified protocol, including assessment of orthostatic hypertension. Further testing includes electrocardiography, ankle-brachial index, direct ophthalmoscopy, and carotid and cardiac ultrasound. Blood samples are collected and stored at the deep freeze of the Astros premises, and blood count, lipid panel, and liver and kidney function are measured.

The main field of interest is the prevalence and burden of risk factors and cardiovascular disease in the wider region of North Kynouria, Arcadia Greece. The project aims to assess the epidemiology of CVD and consequently improve public health and engage with the local community through healthy behavioral education.

Study Type

Interventional

Enrollment (Estimated)

7000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Astros, Greece, 220 01
        • Recruiting
        • Astros Health Care Center
        • Contact:
          • Konstantinos Vemmos, MD, PhD
          • Phone Number: 30 6932479087

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • residents of North Kynouria

Exclusion Criteria:

  • under 18,
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient screening
Single group, no masking, receiving the intervention
Behavioral: Patient counselling
Patient counseling, lifestyle modifications, medication evaluation, and adherence
Other Names:
  • lifestyle modifications
  • dietary recommendations
  • smoking cessation
  • physical activity recommendations
  • medication adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: up to 5 years after enrollment
myocardial infarction, ischemic and hemorrhagic stroke
up to 5 years after enrollment
All-cause mortality
Time Frame: up to 5 years after enrollment
Death by any cause, cardiovascular, infection, cancer, other
up to 5 years after enrollment
Hospitalizations
Time Frame: up to 5 years after enrollment
Any cause hospitalization
up to 5 years after enrollment
Emergency room visits
Time Frame: up to 5 years after enrollment
Any cause of emergency room visit
up to 5 years after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New diagnosis of Arterial hypertension
Time Frame: up to 1 year after enrollment
Any diagnosis of arterial hypertension, masked, white-coat, nocturnal
up to 1 year after enrollment
New diagnosis of diabetes mellitus
Time Frame: up to 1 year after enrollment
Type 1 or Type 2
up to 1 year after enrollment
New diagnosis of dyslipidemia
Time Frame: up to 1 year after enrollment
New diagnosis or uncontrolled
up to 1 year after enrollment
New diagnosis of carotid atherosclerosis
Time Frame: up to 1 year after enrollment
Evaluation of carotid artery stenosis
up to 1 year after enrollment
New diagnosis of peripheral artery disease
Time Frame: up to 1 year after enrollment
Ankle Brachial Index evaluation
up to 1 year after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ioannina

Collaborators

Greece 2021 Committee
Hellenic Stroke Organization
Municipality of North Kynouria
Astros Health Care Center

Investigators

  • Principal Investigator: Charalampos Milionis, MD, PhD, University of Ioannina
  • Principal Investigator: George Ntaios, MD, MSc, PhD, University of Thessaly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The North Kynouria Project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol details

IPD Sharing Time Frame

2024-2025

IPD Sharing Access Criteria

Through access granting from the University of Ioannina

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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