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Factors Influencing Cardiovascular Prognosis (Pythia-GR)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Aristotle University Of Thessaloniki
Sponsor:
Information provided by (Responsible Party):
Vasilios Kotsis, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00973206
First received: September 8, 2009
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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


Condition
Cardiovascular Mortality

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Influencing Cardiovascular Prognosis in Hypertensive Patients (Pythia Study)

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Cardiovascular mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospitalization for CV events [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: January 2017
Estimated Study Completion Date: January 2027
Estimated Primary Completion Date: January 2027 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973206

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

Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Study Chair: Vasilios Kotsis, Prof AUTH
  More Information

No publications provided

Responsible Party: Vasilios Kotsis, Prof. Med, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00973206     History of Changes
Other Study ID Numbers: AUTH20090609
Study First Received: September 8, 2009
Last Updated: June 24, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:
cardiovascular morbidity
mortality community study

ClinicalTrials.gov processed this record on November 25, 2014