Renal DialysisNCT00921089
Vascular Calcification, Inflammation and Coronary Flow Velocity in Hemodialysis Patients
An observational study of Renal Dialysis and Cardiovascular Diseases, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Dialysis, Cardiovascular Diseases, Atherosclerosis
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2008to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
Istanbul, 34390
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Dialysis, Cardiovascular Diseases, Atherosclerosis, Inflammation
- Keywords
- Atherosclerosis, Cardiovascular disease, Hemodialysis, Inflammation, Vascular calcification
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Inflammation, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of coronary artery calcium scores measured by electron-beam computerized tomography and coronary flow reserve.
Measured: 3 months
Secondary outcomes (1)
Relationship between coronary artery calcium scores, coronary flow reserve and inflammatory parameters (IL-6,TNF-alpha, hs-CRP).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Investigators
- Alaattin Yildiz, MD, Study director, Division of Nephrology, Istanbul Faculty of Medicine, Istanbul UniversityYasar Caliskan, MD, Principal investigator, Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921089
- Sponsor's protocol ID
- 1926
- Status last verified
- Jun 2009
- First submitted
- 15 Jun 2009
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Among Vascular Calcification, Inflammation and Coronary Flow Velocity in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00921089
- Acronym / sponsor ID
- 1926
- Conditions
- Renal Dialysis, Cardiovascular Diseases, Atherosclerosis, Inflammation
- Keywords
- Atherosclerosis, Cardiovascular disease, Hemodialysis, Inflammation, Vascular calcification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- Valvular heart disease
- Prior myocardial infarction
- Any prior coronary intervention
- Dilated or hypertrophic cardiomyopathy
- Congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of coronary artery calcium scores measured by electron-beam computerized tomography and coronary flow reserve.
Time frame: 3 months
1 secondary outcome
Relationship between coronary artery calcium scores, coronary flow reserve and inflammatory parameters (IL-6,TNF-alpha, hs-CRP).
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaattin Yildiz, MD study director
Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Yasar Caliskan, MD principal investigator
Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Dialysis and Cardiovascular Diseases, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of coronary artery calcium scores measured by electron-beam computerized tomography and coronary flow reserve. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2009.