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
  Purpose

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.


Condition
Renal Dialysis
Cardiovascular Diseases
Atherosclerosis
Inflammation

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Association Among Vascular Calcification, Inflammation and Coronary Flow Velocity in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 103
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921089

Locations
Turkey
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
Istanbul, Turkey, 34390
Sponsors and Collaborators
Istanbul University
Investigators
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
  More Information

No publications provided

Responsible Party: Alaattin Yildiz, Istanbul Faculty of Medicine, Istanbul University
ClinicalTrials.gov Identifier: NCT00921089     History of Changes
Other Study ID Numbers: 1926
Study First Received: June 15, 2009
Last Updated: June 16, 2009
Health Authority: Turkey: Ministry of Health

Keywords provided by Istanbul University:
Atherosclerosis
Cardiovascular disease
Hemodialysis
Inflammation
Vascular calcification

Additional relevant MeSH terms:
Atherosclerosis
Calcinosis
Cardiovascular Diseases
Inflammation
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014