Clinical trial NCT06115213: The North Kynouria Project
Official title: Mass Screening of the Population of the North Kynouria Municipality in Arcadia, Greece for the Detection of Cardiovascular and Stroke Risk Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Heart Diseases
Cerebrovascular Disease
Coronary Disease
Dyslipidemias
Stroke (CVA) or TIA
Myocardial Infarction
Hypertension
Diabetes Mellitus
Peripheral Artery Disease
Keywords: Atherosclerosis
Vascular Disease
Arterial Occlusive Diseases
Lead sponsor: University Hospital, Ioannina
Sponsor class: OTHER
Collaborators: name: Hellenic Stroke Organization
name: Municipality of North Kynouria
name: Greece 2021 Committee
name: Astros Health Care Center
First posted: 2023-11-02
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* residents of North Kynouria

Exclusion Criteria:

* under 18,
* pregnancy

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: up to 5 years after enrollment
measure: All-cause mortality
timeFrame: up to 5 years after enrollment
measure: Hospitalizations
timeFrame: up to 5 years after enrollment
measure: Emergency room visits
timeFrame: up to 5 years after enrollment
Secondary outcomes:
measure: New diagnosis of Arterial hypertension
timeFrame: up to 1 year after enrollment
measure: New diagnosis of diabetes mellitus
timeFrame: up to 1 year after enrollment
measure: New diagnosis of dyslipidemia
timeFrame: up to 1 year after enrollment
measure: New diagnosis of carotid atherosclerosis
timeFrame: up to 1 year after enrollment
measure: New diagnosis of peripheral artery disease
timeFrame: up to 1 year after enrollment
Other outcomes:
Locations:
city: Astros
country: Greece
facility: Astros Health Care Center
Study officials:
affiliation: University of Ioannina
name: Charalampos Milionis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: George Ntaios, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: