The North Kynouria Project

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115213
• Other study ID #: The North Kynouria Project
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Ioannina
• Contact: Charalampos Milionis, MD, PhD
• Email: hmilioni[@]uoi.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• residents of North Kynouria

Exclusion Criteria:

• under 18,

• pregnancy

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Coronary Disease
• Diabetes Mellitus
• Dyslipidemias
• Heart Diseases
• Hypertension
• Infarction
• Myocardial Infarction
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Stroke (CVA) or TIA

Intervention

Behavioral:
• Patient counselling
Patient counseling, lifestyle modifications, medication evaluation, and adherence

Locations

Country	Name	City	State
Greece	Astros Health Care Center	Astros

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Ioannina	Astros Health Care Center, Greece 2021 Committee, Hellenic Stroke Organization, Municipality of North Kynouria

Country where clinical trial is conducted

Greece, 

Outcome

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