Electro Stethoscope in Detect Arteriovenous Fistula (AVF) Stenosis

NCT01512927 | Unknown

• 1 other identifier: 201112015RIC
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence and prevalence of end-stage renal disease (ESRD) in Taiwan are both the highest worldwide from 2001 to 2008. In Taiwan, more than 90% of the ESRD patients are hemodialysis patients. Either arteriovenous fistula (AVF) or arteriovenous graft (AV graft) is essential for the vascular access of these patients. However, frequent AVF stenosis or thrombosis occurs in 10-30% hemodialytic patients, and the rates are even higher, around 30-70%, in those who has a past history of AVF/AV graft stenosis. Therefore, early detection of AVF stenosis is essential in caring for these hemodialysis patients in terms of medical economics and psychological impact. Unfortunately, angiographic study is expensive and invasive and needs contrast medium injection. The diagnostic accuracy of color duplex ultrasound in AVF stenosis remains satisfactory, but it is not always available when decreased AVF flow or an acute thrombotic event occurs. Continuous AVF/ AV graft flow monitoring by patient himself is a better option in terms of long-term care. Previous study indicated that stethoscope waveform analysis could be used as an alternative to diagnosis of vascular stenosis. Therefore, we aim to investigate AVF/ AV graft stenosis by using the electronic stethoscope (3M Littmann) for AVF sound recording, followed by software analysis by using waveform decomposition, principle component analysis (PCA) and sequential forward selection algorithm \[xx\]. Our study results will provide a new diagnostic option, which is low cost, non-invasive and self-monitoring, of AVF stenosis in ESRD patients.

Conditions

Arteriovenous Fistula

Keywords

electronic stethoscope; arteriovenous fistula; hemodialysis,

Study Arms (1)

ESRD with regular hemodialysis

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

150

You may qualify if:

• Age is more than 20 year-old.
• End-stage renal disease with regular hemodialysis for more than one year

You may not qualify if:

• \. AVF/ AV graft is not located in upper arm.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong-Feng Yeih, Ph.D.

  No.7, Chung Shan S. Rd., Zhongzheng Dist., Taipei City 100, Taiwan (R.O.C.)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DONG-FENG YEIH, Ph.D.

CONTACT

886-2-23123456

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University Hospital

Study Record Dates

• First Submitted: January 15, 2012
• First Posted: January 19, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

TW (1)