Cardiovascular DiseasesNCT06115213
The North Kynouria Project
A study testing Patient counselling in people with Cardiovascular Diseases and Heart Diseases, run by University Hospital, Ioannina at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Disease
- What is being tested?
- Patient counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 1 siteGreece
- Study dates
- 1 Nov 2022to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- residents of North Kynouria
Who cannot join
- under 18,
- pregnancy
Trial locations and contacts
1 site in 1 country.
Charalampos Milionis, MD, PhD contact
Greece1 site, 1 recruiting
- Recruiting
Astros Health Care Center
Ástros, 220 01
Konstantinos Vemmos, MD, PhD, 6932479087 ext. 30
About this study
Official title: Mass Screening of the Population of the North Kynouria Municipality in Arcadia, Greece for the Detection of Cardiovascular and Stroke Risk Factors
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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Disease, Coronary Disease, Dyslipidemias, Stroke (CVA) or TIA
- Being tested
- Patient counselling
- Keywords
- Atherosclerosis, Vascular Disease, Arterial Occlusive Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Disorders, Coronary Disease, Dyslipidemias, Stroke, Myocardial Infarction, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient counsellingBehavioural
Also called lifestyle modifications, dietary recommendations, smoking cessation, physical activity recommendations
Patient counseling, lifestyle modifications, medication evaluation, and adherence
| Study group | Role | What they receive |
|---|---|---|
| Patient screening | Experimental | Single group, no masking, receiving the intervention Receives: Behavioral: Patient counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
myocardial infarction, ischemic and hemorrhagic stroke
Measured: up to 5 years after enrollment
All-cause mortality
Death by any cause, cardiovascular, infection, cancer, other
Measured: up to 5 years after enrollment
Hospitalizations
Any cause hospitalization
Measured: up to 5 years after enrollment
Emergency room visits
Any cause of emergency room visit
Measured: up to 5 years after enrollment
Secondary outcomes (5)
New diagnosis of Arterial hypertension
Any diagnosis of arterial hypertension, masked, white-coat, nocturnal
Measured: up to 1 year after enrollment
New diagnosis of diabetes mellitus
Type 1 or Type 2
Measured: up to 1 year after enrollment
New diagnosis of dyslipidemia
New diagnosis or uncontrolled
Measured: up to 1 year after enrollment
New diagnosis of carotid atherosclerosis
Evaluation of carotid artery stenosis
Measured: up to 1 year after enrollment
New diagnosis of peripheral artery disease
Ankle Brachial Index evaluation
Measured: up to 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Nov 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ioannina
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Stroke Organization, Municipality of North Kynouria, Greece 2021 Committee, Astros Health Care Center
- Responsible party
- Principal investigator, Liontos Angelos, University Hospital, Ioannina
- Investigators
- Charalampos Milionis, MD, PhD, Principal investigator, University of IoanninaGeorge Ntaios, MD, MSc, PhD, Principal investigator, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115213
- Sponsor's protocol ID
- The North Kynouria Project
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol details
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Screening of the Population of the North Kynouria Municipality in Arcadia, Greece for the Detection of Cardiovascular and Stroke Risk Factors
- ClinicalTrials.gov ID
- NCT06115213
- Acronym / sponsor ID
- The North Kynouria Project
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Disease, Coronary Disease, Dyslipidemias, Stroke (CVA) or TIA
- Keywords
- Atherosclerosis, Vascular Disease, Arterial Occlusive Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University Hospital, IoanninaUniversity, hospital or other
- Collaborators
- Hellenic Stroke Organization, Municipality of North Kynouria, Greece 2021 Committee, Astros Health Care Center
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient screening | Experimental | Behavioral: Patient counsellingSingle group, no masking, receiving the intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- residents of North Kynouria
Key exclusion criteria (2 listed)
- under 18,
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient counsellingAlso: lifestyle modifications, dietary recommendations, smoking cessation, physical activity recommendationsPatient counseling, lifestyle modifications, medication evaluation, and adherence | Behavioural | Patient screening |
Primary outcome
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
Emergency room visits
Time frame: up to 5 years after enrollment
Any cause of emergency room visit
5 secondary outcomes
New diagnosis of Arterial hypertension
Time frame: up to 1 year after enrollment
New diagnosis of diabetes mellitus
Time frame: up to 1 year after enrollment
New diagnosis of dyslipidemia
Time frame: up to 1 year after enrollment
New diagnosis of carotid atherosclerosis
Time frame: up to 1 year after enrollment
New diagnosis of peripheral artery disease
Time frame: up to 1 year after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: Yes. Study protocol details
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charalampos Milionis, MD, PhD contact
Charalampos Milionis, MD, PhD principal investigator
University of Ioannina
George Ntaios, MD, MSc, PhD principal investigator
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient counselling in people with Cardiovascular Diseases and Heart Diseases, run by University Hospital, Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charalampos Milionis, MD, PhD (hmilioni@uoi.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: up to 5 years after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.