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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Peritoneal Dialysis; End-stage Renal Disease; Peripheral Artery Occlusion; Aortic Calcification

• Study Type: Observational
• Enrollment (Actual): 174

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital (NTUH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

PD patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PD-ABI; Patients at National Taiwan University Hospital (NTUH); Patients who have received PD more than 3 months; Patients who sign the informed consents; Patients who aged between 20-90 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: September 15, 2013
• First Posted (ESTIMATE): September 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 15, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: peritoneal dialysis; metabolic syndrome; Calcification; aortic pulse wave velocity; peripheral artery occlusion disease
• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Calcium Metabolism Disorders; Cardiovascular Diseases; Kidney Failure, Chronic; Arterial Occlusive Diseases; Calcinosis
• Other Study ID Numbers: 201105097RC