The North Kynouria Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: Patient counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: residents of North Kynouria Exclusion Criteria: under 18, pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient screening<br>Single group, no masking, receiving the intervention | Behavioral: Patient counselling<br>* Patient counseling, lifestyle modifications, medication evaluation, and adherence<br>* Other names: medication adherence;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Vascular Disease, Arterial Occlusive Diseases