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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01945255
• Other study ID #: 201112007RIC
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2013
• Last updated: April 11, 2014
• Start date: March 2012
• Est. completion date: December 2016

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: Jenq-Wen Huang, Doctor
• Phone: +886-2-2312-3456
• Email: 007378[@]ntuh.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Calcification
• Arterial Occlusive Diseases
• Calcinosis
• Cardiovascular Disease
• Cardiovascular Diseases
• End-stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic
• Peripheral Artery Occlusion

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital (NTUH)	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	Yes