Vascular Calcification, Inflammation and Coronary Flow Velocity in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00921089
First received: June 15, 2009
Last updated: June 16, 2009
Last verified: June 2009

June 15, 2009
June 16, 2009
April 2008
July 2008   (final data collection date for primary outcome measure)
Comparison of coronary artery calcium scores measured by electron-beam computerized tomography and coronary flow reserve. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00921089 on ClinicalTrials.gov Archive Site
Relationship between coronary artery calcium scores, coronary flow reserve and inflammatory parameters (IL-6,TNF-alpha, hs-CRP). [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
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Vascular Calcification, Inflammation and Coronary Flow Velocity in Hemodialysis Patients
The Association Among Vascular Calcification, Inflammation and Coronary Flow Velocity in Hemodialysis Patients

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.

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.

Observational
Time Perspective: Cross-Sectional
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Probability Sample

End stage renal disease patients and normotensive healthy controls were studied for the assessment of coronary artery calcification score by electron-beam computerized tomography and coronary flow reserve trans-thoracic Doppler harmonic echocardiographyby.

  • Renal Dialysis
  • Cardiovascular Diseases
  • Atherosclerosis
  • Inflammation
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  • Hemodialysis group
    End stage renal disease patients aged lower than 70 years, treated for more than 6 months with hemodialysis
  • Control group
    Normotensive healthy controls
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
December 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00921089
1926
No
Alaattin Yildiz, Istanbul Faculty of Medicine, Istanbul University
Istanbul University
Not Provided
Study Director: Alaattin Yildiz, MD Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Principal Investigator: Yasar Caliskan, MD Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Istanbul University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP