Clinical trial NCT01945255: The Relationship Between Aortic Pulse Wave and Peripheral Artery Occlusion Disease in Hemodialysis Patients
Official title: The Relationship Between Aortic Pulse Wave and Peripheral Artery Occlusion Disease in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End-stage Renal Disease
Hemodialysis
Aortic Calcification
Peripheral Artery Occlusion
Cardiovascular Disease
Keywords: Calcification
aortic pulse wave velocity
peripheral artery occlusion disease
hemodialysis
metabolic syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HD patients

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
Study officials:
References: