- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00921089
Vascular Calcification, Inflammation and Coronary Flow Velocity in Hemodialysis Patients
June 16, 2009 updated by: Istanbul University
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
103
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34390
- Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hemodialysis group
End stage renal disease patients aged lower than 70 years, treated for more than 6 months with hemodialysis
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Control group
Normotensive healthy controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of coronary artery calcium scores measured by electron-beam computerized tomography and coronary flow reserve.
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relationship between coronary artery calcium scores, coronary flow reserve and inflammatory parameters (IL-6,TNF-alpha, hs-CRP).
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yasar Caliskan, MD, Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
- Study Director: Alaattin Yildiz, MD, Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
June 15, 2009
First Submitted That Met QC Criteria
June 15, 2009
First Posted (Estimate)
June 16, 2009
Study Record Updates
Last Update Posted (Estimate)
June 17, 2009
Last Update Submitted That Met QC Criteria
June 16, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1926
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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