The North Kynouria Project

NCT ID: NCT06115213

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

7000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient screening

Single group, no masking, receiving the intervention

Group Type EXPERIMENTAL

Patient counselling

Intervention Type BEHAVIORAL

Patient counseling, lifestyle modifications, medication evaluation, and adherence

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patient counselling

Patient counseling, lifestyle modifications, medication evaluation, and adherence

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

lifestyle modifications dietary recommendations smoking cessation physical activity recommendations medication adherence

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* residents of North Kynouria

Exclusion Criteria

* under 18,
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hellenic Stroke Organization

UNKNOWN

Sponsor Role collaborator

Municipality of North Kynouria

UNKNOWN

Sponsor Role collaborator

Greece 2021 Committee

OTHER_GOV

Sponsor Role collaborator

Astros Health Care Center

UNKNOWN

Sponsor Role collaborator

University Hospital, Ioannina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Liontos Angelos

MD, MSc, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Charalampos Milionis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ioannina

George Ntaios, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Astros Health Care Center

Ástros, , Greece

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Greece

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Charalampos Milionis, MD, PhD

Role: CONTACT

George Ntaios, MD, PhD

Role: CONTACT

6972770288

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Konstantinos Vemmos, MD, PhD

Role: primary

6932479087 ext. 30

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

The North Kynouria Project

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Active Ageing and Health
NCT03858114 COMPLETED NA