NCT01263301

Brief Summary

Subclavian steal phenomenon is normally observed in patients with stenosis of subclavian artery proximal to orifice of vertebral artery(V0). However, uremic patients undergoing hemodialysis using vascular access in the arm or forearm may also develop dialysis associated steal syndrome(DASS).For patients with symptomatic subclavian steal phenomenon, the treatment for these two groups is different. The investigators want to see if the investigators can use noninvasive duplex examination instead of invasive conventional angiography to do the differential diagnosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 1, 2013

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

11 months

First QC Date

December 16, 2010

Results QC Date

July 9, 2011

Last Update Submit

February 3, 2013

Conditions

Keywords

subclavian stealcarotid duplexsubclavian stenosishemodialysis with vascular access in the upper limbsthe focus of this study is to see if duplex can be used as an tool to differentiate the different causes of subclavian steal syndromes

Outcome Measures

Primary Outcomes (4)

  • Change of Subclavian Flow to Normal Flow Pattern During Cuff Test

    we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.

    two years

  • no Change of Subclavian Arterial Flow During Cuff Test

    we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.

    one year

  • Change of Vertebral Flow to Normal Flow Pattern During Cuff Test

    we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.

    two year

  • no Change of Vertebral Arterial Flow During Cuff Test

    we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.

    2 years

Study Arms (2)

carotid duplex for hemolytic patients wtih SSS

ACTIVE COMPARATOR

assigned intervention:carotid duplex

Device: carotid duplex

carotid duplex for nonhemolytic patients with SSS

ACTIVE COMPARATOR
Device: carotid duplex

Interventions

Carotid duplex in the differential diagnosis of subclavian steal syndrome due to Arteriovenous Hemodialysis access in the Ipsilateral arm

Also known as: steal syndrome
carotid duplex for hemolytic patients wtih SSScarotid duplex for nonhemolytic patients with SSS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who revealed subclavian steal in the duplex study

You may not qualify if:

  • patients who has vascular access in the arm instead of the forearm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mennonite Christial Hospital

Hualien City, Taiwan, 970, Taiwan

Location

MeSH Terms

Conditions

Subclavian Steal Syndrome

Condition Hierarchy (Ancestors)

Vertebrobasilar InsufficiencyBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

the number of the study is small, no standard technique for measurement of blood flow of vascular access

Results Point of Contact

Title
Ling-Chih Wu MD
Organization
Mennonite Christian Hospital

Study Officials

  • lingchih wu

    Mennonite Christian Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

December 16, 2010

First Posted

December 20, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 12, 2013

Results First Posted

February 1, 2013

Record last verified: 2013-02

Locations