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Clinical Trials/NCT06115213
NCT06115213
Recruiting
Not Applicable

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

University Hospital, Ioannina1 site in 1 country7,000 target enrollmentStarted: November 1, 2022Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
University Hospital, Ioannina
Enrollment
7,000
Locations
1
Primary Endpoint
Emergency room visits

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • residents of North Kynouria

Exclusion Criteria

  • under 18,
  • pregnancy

Outcomes

Primary Outcomes

Emergency room visits

Time Frame: up to 5 years after enrollment

Any cause of emergency room visit

Major adverse cardiovascular events

Time Frame: up to 5 years after enrollment

myocardial infarction, ischemic and hemorrhagic stroke

All-cause mortality

Time Frame: up to 5 years after enrollment

Death by any cause, cardiovascular, infection, cancer, other

Hospitalizations

Time Frame: up to 5 years after enrollment

Any cause hospitalization

Secondary Outcomes

  • New diagnosis of diabetes mellitus(up to 1 year after enrollment)
  • New diagnosis of Arterial hypertension(up to 1 year after enrollment)
  • New diagnosis of carotid atherosclerosis(up to 1 year after enrollment)
  • New diagnosis of peripheral artery disease(up to 1 year after enrollment)
  • New diagnosis of dyslipidemia(up to 1 year after enrollment)

Investigators

Sponsor
University Hospital, Ioannina
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Liontos Angelos

MD, MSc, PhD

University Hospital, Ioannina

Study Sites (1)

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