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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01945203
First Posted: September 18, 2013
Last Update Posted: September 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Between Aortic Pulse Wave, Aortic Calcification and Peripheral Artery Occlusion Disease in Peritoneal Dialysis Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
Plasma, 8ml/patient

Enrollment: 174
Study Start Date: December 2011
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
PD patients
Criteria

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:

  1. Patients who refuse to sign informed consents
  2. Patients who refuse to draw additional blood for research
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945203


Locations
Taiwan
National Taiwan University Hospital (NTUH)
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01945203     History of Changes
Other Study ID Numbers: 201105097RC
First Submitted: September 9, 2013
First Posted: September 18, 2013
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by National Taiwan University Hospital:
Calcification
aortic pulse wave velocity
peripheral artery occlusion disease
peritoneal dialysis
metabolic syndrome

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Failure, Chronic
Calcinosis
Arterial Occlusive Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vascular Diseases