The North Kynouria Project

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: Myocardial Infarction; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Hypertension; Diabetes Mellitus; Dyslipidemias; Peripheral Artery Disease; Cerebrovascular Disease; Stroke (CVA) or TIA
• Intervention / Treatment: Behavioral: Patient counselling

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

• Study Contact: Name: Charalampos Milionis, MD, PhD; Email: hmilioni@uoi.gr
• Study Contact Backup: Name: George Ntaios, MD, PhD; Phone Number: 6972770288; Email: gntaios@med.uth.gr

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	myocardial infarction, ischemic and hemorrhagic stroke	up to 5 years after enrollment
All-cause mortality	Death by any cause, cardiovascular, infection, cancer, other	up to 5 years after enrollment
Hospitalizations	Any cause hospitalization	up to 5 years after enrollment
Emergency room visits	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	Any diagnosis of arterial hypertension, masked, white-coat, nocturnal	up to 1 year after enrollment
New diagnosis of diabetes mellitus	Type 1 or Type 2	up to 1 year after enrollment
New diagnosis of dyslipidemia	New diagnosis or uncontrolled	up to 1 year after enrollment
New diagnosis of carotid atherosclerosis	Evaluation of carotid artery stenosis	up to 1 year after enrollment
New diagnosis of peripheral artery disease	Ankle Brachial Index evaluation	up to 1 year after enrollment

Collaborators and Investigators

• 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

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: Atherosclerosis; Vascular Disease; Arterial Occlusive Diseases
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Vascular Diseases; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Lipid Metabolism Disorders; Peripheral Vascular Diseases; Myocardial Infarction; Infarction; Heart Diseases; Coronary Disease; Cardiovascular Diseases; Peripheral Arterial Disease; Dyslipidemias; Cerebrovascular Disorders
• 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