Factors Influencing Cardiovascular Prognosis (Pythia-GR)

This study is not yet open for participant recruitment.
Verified September 2009 by Aristotle University Of Thessaloniki
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00973206
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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 2011
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2021 (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
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: Kotsis Vasilios, Hypertension Center Papageorgiou Hosp
ClinicalTrials.gov Identifier: NCT00973206     History of Changes
Other Study ID Numbers: AUTH20090609
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on April 21, 2014