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

NCT01945255 | Unknown DMC

• 1 other identifier: 201112007RIC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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.

  1 year

Study Arms (1)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HD patients

You may qualify if:

• Patients at National Taiwan University Hospital (NTUH)
• patients who have received HD more than 3 months
• Patients who sign the informed consents

You may not qualify if:

• Patients who refuse to sign informed consents
• Patients who refuse to draw additional blood for research

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital (NTUH)

Taipei, Taiwan, 10002, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Kidney Failure, Chronic; Cardiovascular Diseases; Calcinosis; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Central Study Contacts

Jenq-Wen Huang, Doctor

CONTACT

+886-2-2312-3456; 007378@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 18, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

TW (1)