Vascular Calcification, Inflammation and Coronary Flow Velocity in Hemodialysis Patients

NCT ID: NCT00921089

Last Updated: 2009-06-17

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

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-12-31

Brief Summary

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The aim of this cross-sectional study is to determine the correlation of coronary artery calcification as measured by electron-beam computerized tomography and coronary flow reserve measured by trans-thoracic Doppler echocardiography in hemodialysis patients. The investigators also assessed the carotid artery parameters by measuring intima media thickness that can accurately describe the process of arterial wall changes due to atherosclerosis. Possible association of coronary flow reserve with inflammation and arterial calcification in hemodialysis patients was also evaluated.

Detailed Description

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Cardiovascular mortality is a major cause of death in end-stage renal disease (ESRD). Therefore, the identification of coronary artery disease (CAD) in ESRD is an important task for nephrologists. Coronary angiography is the gold standard for detecting extent and severity of coronary atherosclerosis. It was necessary to determine whether coronary angiography, which is an invasive and contrast using procedure, should be performed in all high-risk individuals or whether noninvasive testing could reliably identify patients with critical coronary lesions. The coronary artery calcification (CAC) in uremic patients undergoing hemodialysis reflects the severity of atherosclerotic vascular disease and predicts the cardiovascular events. Recent studies of chronic kidney disease (CKD) patients have shown significant incidence and rapid progression rates of CAC. Coronary electron-beam computerized tomography (EBCT) could be used as screening test to identify cardiovascular disease (CVD) in CKD patients. In coronary artery disease, left ventricular diastolic dysfunction was found to be correlated with reduced coronary flow reserve (CFR) in patients with hypertension and left ventricular hypertrophy. This shows that in patients with vascular calcification, CFR measurement by trans-thoracic Doppler echocardiography (TTDE) as a non-invasive and an easy test has a usage advantage during risk stratification. CFR represents the capacity of the coronary circulation to dilate following an increase in myocardial metabolic demands. By using this method, impairment of CFR can be assessed before development of angiographically detectable stenosis in epicardial coronary arteries and we are able to investigate early coronary microvasculature pathology. The aim of this cross-sectional study, is to determine the correlation of CAC as measured by EBCT and CFR measured by TTDE. We also assessed the carotid artery parameters by measuring intima media thickness that can accurately describe the process of arterial wall changes due to atherosclerosis. Possible association of CFR with inflammation and arterial calcification was also evaluated.

Conditions

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Renal Dialysis Cardiovascular Diseases Atherosclerosis Inflammation

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hemodialysis group

End stage renal disease patients aged lower than 70 years, treated for more than 6 months with hemodialysis

No interventions assigned to this group

Control group

Normotensive healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subject must be 18 years of age or older and able to give informed consent
* End stage renal disease patients treated for more than 6 months with hemodialysis

Exclusion Criteria

* Valvular heart disease
* Prior myocardial infarction
* Any prior coronary intervention
* Dilated or hypertrophic cardiomyopathy
* Congestive heart failure
* Cardiac arrhythmia
* Active infection or non-infectious overt inflammation
* Patients whose LAD could not visualized adequately
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Istanbul Faculty of Medicine, Istanbul University

Principal Investigators

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Alaattin Yildiz, MD

Role: STUDY_DIRECTOR

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Yasar Caliskan, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Locations

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Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1926

Identifier Type: -

Identifier Source: org_study_id

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