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Factors Influencing Cardiovascular Prognosis (Pythia-GR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00973206
Recruitment Status : Not yet recruiting
First Posted : September 9, 2009
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Vasilios Kotsis, Aristotle University Of Thessaloniki

Study Description
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Brief Summary:
The purpose of this study is to identify risks for cardiovascular events in a follow up period of 10 years.

Condition or disease
Cardiovascular Mortality

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
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Influencing Cardiovascular Prognosis in Hypertensive Patients (Pythia Study)
Study Start Date : January 2017
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Hospitalization for CV events [ Time Frame: 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers,community sample, residents of a certain town
Criteria

Inclusion Criteria:

  • All age >50 volunteers

Exclusion Criteria:

  • None
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973206


Contacts
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Contact: Vasilios Kotsis, Prof 6974748860 ext +30 vkotsis@auth.gr

Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Study Chair: Vasilios Kotsis, Prof AUTH
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Vasilios Kotsis, Prof. Med, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00973206    
Other Study ID Numbers: AUTH20090609
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Keywords provided by Vasilios Kotsis, Aristotle University Of Thessaloniki:
cardiovascular morbidity
mortality community study