Factors Influencing Cardiovascular Prognosis

NCT ID: NCT00973206

Last Updated: 2014-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2027-01-31

Brief Summary

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

Detailed Description

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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

Conditions

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Cardiovascular Mortality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All age \>50 volunteers

Exclusion Criteria

* None
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Vasilios Kotsis

Prof. Med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vasilios Kotsis, Prof

Role: STUDY_CHAIR

AUTH

Central Contacts

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Vasilios Kotsis, Prof

Role: CONTACT

6974748860 ext. +30

Other Identifiers

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AUTH20090609

Identifier Type: -

Identifier Source: org_study_id

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