The North Kynouria Project

• Sponsor: University Hospital, Ioannina (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06115213
• Collaborator: Hellenic Stroke Organization (Other), Municipality of North Kynouria (Other), Greece 2021 Committee (Other), Astros Health Care Center (Other)
• Enrollment: 7,000
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 189.4

Study Details

Study Description

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.

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

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
• Anticipated Enrollment: 7000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Mass Screening of the Population of the North Kynouria Municipality in Arcadia, Greece for the Detection of Cardiovascular and Stroke Risk Factors
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Nov 30, 2025
• Anticipated Study Completion Date: Nov 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Major adverse cardiovascular events [up to 5 years after enrollment]

   myocardial infarction, ischemic and hemorrhagic stroke

2. All-cause mortality [up to 5 years after enrollment]

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

3. Hospitalizations [up to 5 years after enrollment]

   Any cause hospitalization

4. Emergency room visits [up to 5 years after enrollment]

   Any cause of emergency room visit

Secondary Outcome Measures

1. New diagnosis of Arterial hypertension [up to 1 year after enrollment]

   Any diagnosis of arterial hypertension, masked, white-coat, nocturnal

2. New diagnosis of diabetes mellitus [up to 1 year after enrollment]

   Type 1 or Type 2

3. New diagnosis of dyslipidemia [up to 1 year after enrollment]

   New diagnosis or uncontrolled

4. New diagnosis of carotid atherosclerosis [up to 1 year after enrollment]

   Evaluation of carotid artery stenosis

5. New diagnosis of peripheral artery disease [up to 1 year after enrollment]

   Ankle Brachial Index evaluation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• residents of North Kynouria

Exclusion Criteria:

• under 18,

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Astros Health Care Center	Astros		Greece	220 01

Sponsors and Collaborators

• University Hospital, Ioannina
• Hellenic Stroke Organization
• Municipality of North Kynouria
• Greece 2021 Committee
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liontos Angelos, MD, MSc, PhD, University Hospital, Ioannina
• ClinicalTrials.gov Identifier: NCT06115213
• Other Study ID Numbers: The North Kynouria Project
• First Posted: Nov 2, 2023
• Last Update Posted: Nov 2, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Liontos Angelos, MD, MSc, PhD, University Hospital, Ioannina: Atherosclerosis; Vascular Disease; Arterial Occlusive Diseases
• Additional relevant MeSH terms: Cerebrovascular Disorders; Cardiovascular Diseases; Myocardial Infarction; Heart Diseases; Coronary Disease; Peripheral Arterial Disease; Dyslipidemias; Infarction

Study Results

No Results Posted as of Nov 2, 2023