- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01263301
Differential Diagnosis for the Causes of Subclavian Steal for Patients With Vascular Access in the Forearm
February 3, 2013 updated by: Ling-Chih, Wu, Mennonite Christian Hospital
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.
Study Overview
Detailed Description
Carotid duplex is widely used for diagnosis of subclavian steal syndrome.
We have a patient who suffered from acute brain stem stroke after receiving hemodialysis for months.
He has DM related uremia and the vascular access is in the forearm.
Subclavian steal was found on duplex in the same arm for hemodialysis.
We used standard cuff test for diagnosis of subclavian steal by carotid duplex examination.
Accidentally, we found the flow of subclavian artery was back to normal when the cuff is on that stops the flow.
We want to see if this phenomenon can be used to serve as a differential diagnostic tool for differentiation of subclavian steal caused by stenosis of subclavian artery or due to DASS.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hua Lien, Taiwan, 970
- Mennonite Christial Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients who revealed subclavian steal in the duplex study
Exclusion Criteria:
- patients who has vascular access in the arm instead of the forearm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: carotid duplex for hemolytic patients wtih SSS
assigned intervention:carotid duplex
|
Carotid duplex in the differential diagnosis of subclavian steal syndrome due to Arteriovenous Hemodialysis access in the Ipsilateral arm
Other Names:
|
|
Active Comparator: carotid duplex for nonhemolytic patients with SSS
|
Carotid duplex in the differential diagnosis of subclavian steal syndrome due to Arteriovenous Hemodialysis access in the Ipsilateral arm
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Subclavian Flow to Normal Flow Pattern During Cuff Test
Time Frame: two years
|
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
Time Frame: one year
|
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
Time Frame: two year
|
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
Time Frame: 2 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: lingchih wu, Mennonite Christian Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
December 16, 2010
First Submitted That Met QC Criteria
December 17, 2010
First Posted (Estimate)
December 20, 2010
Study Record Updates
Last Update Posted (Estimate)
February 12, 2013
Last Update Submitted That Met QC Criteria
February 3, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-06-024-ER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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