Cardiovascular MortalityPythia-GRNCT00973206
Factors Influencing Cardiovascular Prognosis
An observational study of Cardiovascular Mortality, run by Aristotle University Of Thessaloniki.
Trial summary
The purpose of this study is to identify risks for cardiovascular events in a follow up period of 10 years. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Mortality
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers,community sample, residents of a certain town
Who may be able to join
- All age >50 volunteers
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Factors Influencing Cardiovascular Prognosis in Hypertensive Patients (Pythia Study)
The purpose of this study is to identify risks for cardiovascular events in a follow up period of 10 years.
Read the detailed description
Inclusion criteria
- Age > 50 years volunteers (2 towns of 15000 residents one in the north and one in the south of Greece)
- End points
- 5-10 years cardiovascular morbidity and mortality
Measurements at baseline
- Anthropometrics
- Age (M>55 years; W>65 years)
- Weight-height- BMI
- Abdominal obesity (Waist circumference>102 cm(M), >88cm (W) Family history
- Family history of premature CV disease (M at age<55 years; W at age<65 years)
History
- Smoking
- Diabetes Mellitus,
- Established Heart disease: myocardial infarction; angina; coronary revascularization; heart failure
- Established renal disease [diabetic nephropathy; renal impairment (serum creatinine M>133, W>124 mmol/l); proteinuria (> 300 mg/24 h)]
- Cerebrovascular disease: ischaemic stroke; cerebral haemorrhage; transient ischaemic attack
- Peripheral artery disease
- Advanced retinopathy: haemorrhages or exudates, papilloedema
- Treatment
Measurements
- Measurements Blood pressure
- Clinic BP
- 24h ABPM
- Home BP
Heart
- Electrocardiographic LVH
- Echocardiographic LVH
Vessels
- Carotid wall thickening or plaque
- Carotid-femoral pulse wave velocity
- Ankle/brachial BP index
Lipids or other risk factors
- Total cholesterol, Tg, HDL, LDL
- Plasma creatinine, estimated glomerular filtration rate
- Fasting plasma glucose or postload plasma glucose
- Microalbuminuria and albumin-creatinine ratio
- Glucose tolerance test
- Follow up each 3 year with all the above measurements
- Conditions
- Cardiovascular Mortality
- Keywords
- cardiovascular morbidity, mortality community study
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Measured: 10 years
Secondary outcomes (1)
Hospitalization for CV events
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startJan 2017
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular MortalityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasilios Kotsis, Aristotle University Of Thessaloniki
- Investigators
- Vasilios Kotsis, Prof, Study chair, AUTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973206
- Sponsor's protocol ID
- AUTH20090609
- Acronym
- Pythia-GR
- Status last verified
- Jun 2014
- First submitted
- 8 Sep 2009
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Cardiovascular Prognosis in Hypertensive Patients (Pythia Study)
- ClinicalTrials.gov ID
- NCT00973206
- Acronym / sponsor ID
- Pythia-GR / AUTH20090609
- Conditions
- Cardiovascular Mortality
- Keywords
- cardiovascular morbidity, mortality community study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Sep 2009 (estimated)
- 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 purpose of this study is to identify risks for cardiovascular events in a follow up period of 10 years.
Detailed description
Inclusion criteria
- Age > 50 years volunteers (2 towns of 15000 residents one in the north and one in the south of Greece)
- End points
- 5-10 years cardiovascular morbidity and mortality
Measurements at baseline
- Anthropometrics
- Age (M>55 years; W>65 years)
- Weight-height- BMI
- Abdominal obesity (Waist circumference>102 cm(M), >88cm (W) Family history
- Family history of premature CV disease (M at age<55 years; W at age<65 years)
History
- Smoking
- Diabetes Mellitus,
- Established Heart disease: myocardial infarction; angina; coronary revascularization; heart failure
- Established renal disease [diabetic nephropathy; renal impairment (serum creatinine M>133, W>124 mmol/l); proteinuria (> 300 mg/24 h)]
- Cerebrovascular disease: ischaemic stroke; cerebral haemorrhage; transient ischaemic attack
- Peripheral artery disease
- Advanced retinopathy: haemorrhages or exudates, papilloedema
- Treatment
Measurements
- Measurements Blood pressure
- Clinic BP
- 24h ABPM
- Home BP
Heart
- Electrocardiographic LVH
- Echocardiographic LVH
Vessels
- Carotid wall thickening or plaque
- Carotid-femoral pulse wave velocity
- Ankle/brachial BP index
Lipids or other risk factors
- Total cholesterol, Tg, HDL, LDL
- Plasma creatinine, estimated glomerular filtration rate
- Fasting plasma glucose or postload plasma glucose
- Microalbuminuria and albumin-creatinine ratio
- Glucose tolerance test
- Follow up each 3 year with all the above measurements
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers,community sample, residents of a certain town
Key inclusion criteria (1 listed)
- All age >50 volunteers
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular mortality
Time frame: 10 years
1 secondary outcome
Hospitalization for CV events
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
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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.
Vasilios Kotsis, Prof study chair
AUTH
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Mortality, run by Aristotle University Of Thessaloniki.
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 1 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: opening soon, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vasilios Kotsis, Prof (6974748860 ext. +30, vkotsis@auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (time frame: 10 years). 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 25 Jun 2014.