The North Kynouria Project

NCT06115213 | Unknown

• 1 other identifier: The North Kynouria Project
• Study Type: interventional
• Target: 7,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Major adverse cardiovascular events

  myocardial infarction, ischemic and hemorrhagic stroke

  up to 5 years after enrollment

• All-cause mortality

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

  up to 5 years after enrollment

• Hospitalizations

  Any cause hospitalization

  up to 5 years after enrollment

• Emergency room visits

  Any cause of emergency room visit

  up to 5 years after enrollment

Secondary Outcomes (5)

• New diagnosis of Arterial hypertension

  up to 1 year after enrollment

• New diagnosis of diabetes mellitus

  up to 1 year after enrollment

• New diagnosis of dyslipidemia

  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

Study Arms (1)

Patient screening

EXPERIMENTAL

Single group, no masking, receiving the intervention

Behavioral: Patient counselling

Interventions

Patient counselling BEHAVIORAL

Patient counseling, lifestyle modifications, medication evaluation, and adherence

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

Patient screening

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• residents of North Kynouria

You may not qualify if:

• under 18,
• pregnancy

Sponsors & Collaborators

• University Hospital, Ioannina: lead
• Hellenic Stroke Organization: collaborator
• Municipality of North Kynouria: collaborator
• Greece 2021 Committee: collaborator
• Astros Health Care Center: collaborator

Study Sites (1)

Astros Health Care Center

Ástros, 220 01, Greece

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Cerebrovascular Disorders; Coronary Disease; Dyslipidemias; Stroke; Myocardial Infarction; Hypertension; Diabetes Mellitus; Peripheral Arterial Disease; Atherosclerosis; Vascular Diseases; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Myocardial Ischemia; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Glucose Metabolism Disorders; Endocrine System Diseases; Arteriosclerosis; Peripheral Vascular Diseases

Study Officials

• Charalampos Milionis, MD, PhD

  University of Ioannina

  PRINCIPAL INVESTIGATOR

• George Ntaios, MD, MSc, PhD

  University of Thessaly

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charalampos Milionis, MD, PhD

CONTACT

hmilioni@uoi.gr

George Ntaios, MD, PhD

CONTACT

6972770288; gntaios@med.uth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PhD

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 2, 2023
• Study Start: November 1, 2022
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2024-2025
• Access Criteria: Through access granting from the University of Ioannina

Locations

GR (1)