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Factors Influencing Cardiovascular Prognosis (Pythia-GR)

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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

Tracking Information
First Submitted Date September 8, 2009
First Posted Date September 9, 2009
Last Update Posted Date June 25, 2014
Study Start Date January 2017
Estimated Primary Completion Date January 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2009)
Cardiovascular mortality [ Time Frame: 10 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 8, 2009)
Hospitalization for CV events [ Time Frame: 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Factors Influencing Cardiovascular Prognosis
Official Title Factors Influencing Cardiovascular Prognosis in Hypertensive Patients (Pythia Study)
Brief Summary 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Volunteers,community sample, residents of a certain town
Condition Cardiovascular Mortality
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 8, 2009)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2027
Estimated Primary Completion Date January 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All age >50 volunteers

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Vasilios Kotsis, Prof 6974748860 ext +30 vkotsis@auth.gr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00973206
Other Study ID Numbers AUTH20090609
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Vasilios Kotsis, Aristotle University Of Thessaloniki
Study Sponsor Aristotle University Of Thessaloniki
Collaborators Not Provided
Investigators
Study Chair: Vasilios Kotsis, Prof AUTH
PRS Account Aristotle University Of Thessaloniki
Verification Date June 2014