Cardiovascular DiseaseL5NCT01236820
A Study Using L5 as a Risk Factor of Cardiovascular (CV) Disease in Chronic Renal and Dialytic Patients
An observational study of Cardiovascular Disease and Chronic Kidney Disease Patients, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether L5, one of the Low Density Lipoproteins, is an effective predicting factor for cardiovascular disease in chronic renal and hemodialytic patients. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Chronic Kidney Disease Patients, Hemodialytic Patients
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to not given
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents in Taiwan, mostly in Taichung area
Who may be able to join
- clinical diagnosis of CKD
- clinical diagnosis of HD
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, Taiwan, 404
Chiu-Ching Huang, MD, 886-4-22052121 ext. 2902, cch@mail.cmuh.org.tw
Chiz-Tzung Chang, MD, Ph.D., 886-4-22052121 ext. 2902, D19863@mail.cmuh.org.tw
About this study
Official title: L5 as a Risk Factor of Cardiovascular Disease in Chronic Kidney Disease and Dialysis Patients
The purpose of this study is to determine whether L5, one of the Low Density Lipoproteins, is an effective predicting factor for cardiovascular disease in chronic renal and hemodialytic patients.
Read the detailed description
Cardiovascular disease (CVD) is the most important cause of death of chronic kidney disease (CKD) and hemodialysis (HD) patients. Low Density Lipoprotein (LDL) is an essential indicator of CVD.The higher the plasma LDL level, the higher the risk of CVD. LDL is a heterogenous substance composed of different mass and size. Oxidized LDL (oxLDL) is the oxidation product of LDL and is the most important component of LDL associated with CVD. The oxLDL is mostly trapped within tissue and not easily to be detected from blood. L5 iw a kind of electronegative LDL and is associated with CVD in smokers and diabetic patients, even if these patients have normal plasma LDL. Uremia patients have lipid profile different from that of general people,while HD Patients have lower LDL and CKD patients have LDL higher than that of general population. Thus LDL plasma level cannot fully explain the high risk of CVD in CKD and HD patients. As patients with normal LDL but high L5 are prone to have CVD, we suspect there might be association of L5 with CVD in both CKD and HD patients.
- Conditions
- Cardiovascular Disease, Chronic Kidney Disease Patients, Hemodialytic Patients, High LDL Level, High L5 Level
- Keywords
- L5, LDL, Cardiovascular disease, Chronic kidney disease, Hemodialysis
- Medical subject headings
- Cardiovascular Diseases, Renal Insufficiency, Chronic
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 |
|---|---|---|
| Normal | Healthy population | |
| CKD Patients | Chronic Kidney Disease, in Stage III-V | |
| HD patients | End-stage renal disease patients undergoing hemodialysis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236820
- Sponsor's protocol ID
- CTCHANG001
- Acronym
- L5
- Status last verified
- Nov 2010
- First submitted
- 5 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L5 as a Risk Factor of Cardiovascular Disease in Chronic Kidney Disease and Dialysis Patients
- ClinicalTrials.gov ID
- NCT01236820
- Acronym / sponsor ID
- L5 / CTCHANG001
- Conditions
- Cardiovascular Disease, Chronic Kidney Disease Patients, Hemodialytic Patients, High LDL Level, High L5 Level
- Keywords
- L5, LDL, Cardiovascular disease, Chronic kidney disease, Hemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- First posted
- 9 Nov 2010 (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 purpose of this study is to determine whether L5, one of the Low Density Lipoproteins, is an effective predicting factor for cardiovascular disease in chronic renal and hemodialytic patients.
Detailed description
Cardiovascular disease (CVD) is the most important cause of death of chronic kidney disease (CKD) and hemodialysis (HD) patients. Low Density Lipoprotein (LDL) is an essential indicator of CVD.The higher the plasma LDL level, the higher the risk of CVD. LDL is a heterogenous substance composed of different mass and size. Oxidized LDL (oxLDL) is the oxidation product of LDL and is the most important component of LDL associated with CVD. The oxLDL is mostly trapped within tissue and not easily to be detected from blood. L5 iw a kind of electronegative LDL and is associated with CVD in smokers and diabetic patients, even if these patients have normal plasma LDL. Uremia patients have lipid profile different from that of general people,while HD Patients have lower LDL and CKD patients have LDL higher than that of general population. Thus LDL plasma level cannot fully explain the high risk of CVD in CKD and HD patients. As patients with normal LDL but high L5 are prone to have CVD, we suspect there might be association of L5 with CVD in both CKD and HD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –Healthy population |
| CKD Patients | – | –Chronic Kidney Disease, in Stage III-V |
| HD patients | – | –End-stage renal disease patients undergoing hemodialysis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents in Taiwan, mostly in Taichung area
Key inclusion criteria (2 listed)
- clinical diagnosis of CKD
- clinical diagnosis of HD
Key exclusion criteria (1 listed)
- N/A
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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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.
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 Cardiovascular Disease and Chronic Kidney Disease Patients, run by China Medical University Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2010. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiz-Tzung Chang, Ph.D. (886-4-22052121 ext. 2902, D19863@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 9 Nov 2010.