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CompletedNCT01945203Updated Sep 18, 2013

The Relationship Between Aortic Pulse Wave, Aortic Calcification and Peripheral Artery Occlusion Disease in Peritoneal Dialysis Patients

An observational study in End-stage Renal Disease, Peritoneal Dialysis and Aortic Calcification, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-09-18.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
174
Ages
20 Years to 90 Years
Sex
All
01

Study summary

Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage renal disease (ESRD), which means that it is important to find out risk factors of CVD in order to prevent or treat it. In recent years, there has been more and more recognition of a very high prevalence of CV calcification in the ESRD population. Many observational cohort studies have shown that CV calcification in these patients can predict mortality, CV mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may result in vessel calcification. Calcification leads to arterial stenosis and increasing arterial stiffness and then heart afterload, both contribute to the development of CVD. Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic, immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly associated with the presence and extent of atherosclerosis and constitutes a forceful marker and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which would increase the condition of infection and gangrene. Thus, life safety and quality would be influenced severely and early detection might prevent future amputation. As compared with HD or pre-dialysis patients, uremic patients treated with PD have a higher risk for metabolic syndrome. Therefore, more studies to evaluate the condition of arterial stiffness and PAOD, especially in PD patients, are needed for future management and preventions of CV related morbidity and mortality.

02

Conditions studied

  • End-stage Renal Disease
  • Peritoneal Dialysis
  • Aortic Calcification
  • Peripheral Artery Occlusion
  • Cardiovascular Disease

Keywords

  • Calcification
  • aortic pulse wave velocity
  • peripheral artery occlusion disease
  • peritoneal dialysis
  • metabolic syndrome
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 261 are open to participants now.

This study's enrollment of 174 is above the median of 120 across 431 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

PD patients

Inclusion criteria

  1. Patients at National Taiwan University Hospital (NTUH)
  2. Patients who have received PD more than 3 months
  3. Patients who sign the informed consents

Exclusion criteria

Exclusion Criteria:

  1. Patients who refuse to sign informed consents
  2. Patients who refuse to draw additional blood for research
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
174 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • PD-ABI

    1. Patients at National Taiwan University Hospital (NTUH) 2. Patients who have received PD more than 3 months 3. Patients who sign the informed consents 4. Patients who aged between 20-90 years.

06

What researchers measure

Primary outcomes

  1. Evaluate the associations between aortic pulse wave, ankle-brachial index, aortic calcification and blood/serum biochemical markers, such as MPO, MMP-9, IL-6, adiponectin, TNF-alpha, of the patients in prevalent peritoneal dialysis patients.

    Time frame: 1 year

07

Study locations

1 site
  • National Taiwan University Hospital (NTUH)
    Taipei, 10002, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01945203
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Sep 18, 2013
Start date
Dec 2011
Primary completion
Jul 2013
Last update
Sep 18, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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