A Study Using L5 as a Risk Factor of Cardiovascular (CV) Disease in Chronic Renal and Dialytic Patients

NCT ID: NCT01236820

Last Updated: 2010-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease Chronic Kidney Disease Patients Hemodialytic Patients High LDL Level High L5 Level

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

L5 LDL Cardiovascular disease Chronic kidney disease Hemodialysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal

Healthy population

No interventions assigned to this group

CKD Patients

Chronic Kidney Disease, in Stage III-V

No interventions assigned to this group

HD patients

End-stage renal disease patients undergoing hemodialysis

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* clinical diagnosis of CKD
* clinical diagnosis of HD

Exclusion Criteria

* N/A
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

China Medical University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

China Medical University Hospital

Taichung, Taiwan, Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chiz-Tzung Chang, Ph.D.

Role: CONTACT

Phone: 886-4-22052121

Email: [email protected]

Chiu-Ching Huang, MD

Role: CONTACT

Phone: 886-4-22052121

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chiu-Ching Huang, MD

Role: primary

Chiz-Tzung Chang, MD, Ph.D.

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTCHANG001

Identifier Type: -

Identifier Source: org_study_id