Factors Influencing Cardiovascular Prognosis

Cardiovascular Mortality Clinical Trial

— Pythia-GR  

Official title:

Factors Influencing Cardiovascular Prognosis in Hypertensive Patients (Pythia Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00973206
• Other study ID #: AUTH20090609
• Status: Not yet recruiting
• Phase: N/A
• First received: September 8, 2009
• Last updated: June 24, 2014
• Start date: January 2017
• Est. completion date: January 2027

Study information

• Verified date: June 2014
• Source: Aristotle University Of Thessaloniki
• Contact: Vasilios Kotsis, Prof
• Phone: 6974748860
• Email: vkotsis[@]auth.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• All age >50 volunteers

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Mortality

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality		10 years	No
Secondary	Hospitalization for CV events		10 years	No