Factors Influencing Cardiovascular Prognosis

Not yet recruiting

• Conditions: Cardiovascular Mortality

• Registration Number: NCT00973206
• Lead Sponsor: Aristotle University Of Thessaloniki

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 Timeline

• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-25
• Study Start: 2017-01
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• All age >50 volunteers

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality	10 years

Secondary Outcome Measures

Name	Time	Method
Hospitalization for CV events	10 years