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The Relationship Between Aortic Pulse Wave and Peripheral Artery Occlusion Disease in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT01945255
Recruitment Status : Unknown
Verified April 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 18, 2013
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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. Uremic patients also have a higher risk for metabolic syndrome. Therefore, more studies to evaluate the condition of arterial stiffness and PAOD, especially in HD patients, are needed for future management and preventions of CV related morbidity and mortality.

Condition or disease
End-stage Renal Disease Hemodialysis Aortic Calcification Peripheral Artery Occlusion Cardiovascular Disease

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Between Aortic Pulse Wave and Peripheral Artery Occlusion Disease in Hemodialysis Patients
Study Start Date : March 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Group/Cohort
HD-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



Primary Outcome Measures :
  1. Evaluate the associations between aortic pulse wave, ankle-brachial index, and blood/serum biochemical markers, such as MPO, MMP-9, IL-6, adiponectin, TNF-alpha, of the patients in prevalent hemodialysis patients. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
plasma


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients at National Taiwan University Hospital (NTUH)
  2. patients who have received HD 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

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): NCT01945255


Contacts
Contact: Jenq-Wen Huang, Doctor +886-2-2312-3456 ext 63288 007378@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital (NTUH) Recruiting
Taipei, Taiwan, 10002
Contact: Jenq-Wen Huang, Doctor    +886-2-2312-3456 ext 63288    007378@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01945255     History of Changes
Other Study ID Numbers: 201112007RIC
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014

Keywords provided by National Taiwan University Hospital:
Calcification
aortic pulse wave velocity
peripheral artery occlusion disease
hemodialysis
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