Differential Diagnosis for the Causes of Subclavian Steal for Patients With Vascular Access in the Forearm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ling-Chih, Wu, Mennonite Christian Hospital
ClinicalTrials.gov Identifier:
NCT01263301
First received: December 16, 2010
Last updated: February 3, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Subclavian Steal
Device: carotid duplex

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Differential Diagnosis for the Causes of Subclavian Steal for Patients With Vascular Access in the Forearm

Resource links provided by NLM:


Further study details as provided by Mennonite Christian Hospital:

Primary Outcome Measures:
  • Change of Subclavian Flow to Normal Flow Pattern During Cuff Test [ Time Frame: two years ] [ Designated as safety issue: No ]
    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.

  • no Change of Subclavian Arterial Flow During Cuff Test [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.

  • Change of Vertebral Flow to Normal Flow Pattern During Cuff Test [ Time Frame: two year ] [ Designated as safety issue: No ]
    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.

  • no Change of Vertebral Arterial Flow During Cuff Test [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: carotid duplex for hemolytic patients wtih SSS
assigned intervention:carotid duplex
Device: carotid duplex
Carotid duplex in the differential diagnosis of subclavian steal syndrome due to Arteriovenous Hemodialysis access in the Ipsilateral arm
Other Name: steal syndrome
Active Comparator: carotid duplex for nonhemolytic patients with SSS Device: carotid duplex
Carotid duplex in the differential diagnosis of subclavian steal syndrome due to Arteriovenous Hemodialysis access in the Ipsilateral arm
Other Name: steal syndrome

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01263301

Locations
Taiwan
Mennonite Christial Hospital
Hua Lien, Taiwan, 970
Sponsors and Collaborators
Mennonite Christian Hospital
Investigators
Principal Investigator: lingchih wu Mennonite Christian Hospital
  More Information

No publications provided

Responsible Party: Ling-Chih, Wu, doctor, Mennonite Christian Hospital
ClinicalTrials.gov Identifier: NCT01263301     History of Changes
Other Study ID Numbers: 10-06-024-ER
Study First Received: December 16, 2010
Results First Received: July 9, 2011
Last Updated: February 3, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Mennonite Christian Hospital:
subclavian steal
carotid duplex
subclavian stenosis
hemodialysis with vascular access in the upper limbs
the focus of this study is to see if duplex can be used as an tool to differentiate the different causes of subclavian steal syndromes

Additional relevant MeSH terms:
Subclavian Steal Syndrome
Vertebrobasilar Insufficiency
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014