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RecruitingNCT06115213Updated Nov 2, 2023

The North Kynouria Project

An interventional study of Patient counselling in Cardiovascular Diseases, Heart Diseases and Cerebrovascular Disease, sponsored by University Hospital, Ioannina. Recruiting at 1 site in Greece. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by University Hospital, Ioannina · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Registered 11 months after the study started (first participant enrolled Nov 2022, registered Oct 2023).
  • Started Nov 2022; still recruiting 4 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
7,000
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Cardiovascular Diseases

5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.

This study's planned enrollment of 7,000 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University Hospital, Ioannina is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • residents of North Kynouria

Exclusion criteria

Exclusion Criteria:

  • under 18,
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7,000 participants (estimated)

Study arms

  • Experimental
    Patient screening

    Single group, no masking, receiving the intervention

    Behavioral: Patient counselling

Interventions

  • BehavioralPatient counselling

    Patient counseling, lifestyle modifications, medication evaluation, and adherence

    Also known as: lifestyle modifications, dietary recommendations, smoking cessation, physical activity recommendations, medication adherence

06

What researchers measure

Primary outcomes

  1. Major adverse cardiovascular events

    myocardial infarction, ischemic and hemorrhagic stroke

    Time frame: up to 5 years after enrollment

  2. All-cause mortality

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

    Time frame: up to 5 years after enrollment

  3. Hospitalizations

    Any cause hospitalization

    Time frame: up to 5 years after enrollment

  4. Emergency room visits

    Any cause of emergency room visit

    Time frame: up to 5 years after enrollment

Secondary outcomes

  1. New diagnosis of Arterial hypertension

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

    Time frame: up to 1 year after enrollment

  2. New diagnosis of diabetes mellitus

    Type 1 or Type 2

    Time frame: up to 1 year after enrollment

  3. New diagnosis of dyslipidemia

    New diagnosis or uncontrolled

    Time frame: up to 1 year after enrollment

  4. New diagnosis of carotid atherosclerosis

    Evaluation of carotid artery stenosis

    Time frame: up to 1 year after enrollment

  5. New diagnosis of peripheral artery disease

    Ankle Brachial Index evaluation

    Time frame: up to 1 year after enrollment

07

Study locations

1 of 1 sites recruiting
  • Astros Health Care Center
    Astros, 220 01, Greece
    Recruiting
    • Konstantinos Vemmos, MD, PhD · Contact6932479087
08

References and documents

Individual participant data

Plan to share: Yes — Study protocol details

Supporting information: Study protocol

Time frame: 2024-2025

Access criteria: Through access granting from the University of Ioannina

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06115213
Lead sponsor
University Hospital, Ioannina
Collaborators
Hellenic Stroke Organization, Municipality of North Kynouria, Greece 2021 Committee, Astros Health Care Center
Responsible party
Liontos Angelos (MD, MSc, PhD, University Hospital, Ioannina) — Principal investigator
First posted
Nov 2, 2023
Start date
Nov 1, 2022
Primary completion
Nov 30, 2025 (estimated)
Completion
Nov 30, 2025 (estimated)
Last update
Nov 2, 2023

Study contacts

Charalampos Milionis, MD, PhD
Contact
hmilioni@uoi.gr
George Ntaios, MD, PhD
Contact
gntaios@med.uth.gr
6972770288
Charalampos Milionis, MD, PhD
principal investigator · University of Ioannina
George Ntaios, MD, MSc, PhD
principal investigator · University of Thessaly

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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