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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01263301
Enrollment
16
Registered
2010-12-20
Start date
2010-08-31
Completion date
2011-07-31
Last updated
2013-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subclavian Steal

Keywords

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

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.

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.

Interventions

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

Sponsors

Mennonite Christian Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Subclavian Flow to Normal Flow Pattern During Cuff Testtwo yearswe 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 Testone yearwe 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 Testtwo yearwe 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 Test2 yearswe 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.

Countries

Taiwan

Participant flow

Recruitment details

enroll patients from Dec 2010 to July 2011. all enrolled patients have been studied by carotid duplex in Mennonite Christian hospital.

Pre-assignment details

one patient with vascular access has been ruled out after enrollment for the subclavian artery revealed normal blood flow in duplex.

Participants by arm

ArmCount
Carotid Duplex for Nonhemodialytic Patients Wtih SSS
using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
5
Carotid Duplex for Hemodialytic Patients With SSS
After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
2
Total7

Baseline characteristics

CharacteristicCarotid Duplex for Hemodialytic Patients With SSSCarotid Duplex for Nonhemodialytic Patients Wtih SSSTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants2 Participants2 Participants
Age, Categorical
Between 18 and 65 years
2 Participants3 Participants5 Participants
Age Continuous52.5 years
STANDARD_DEVIATION 0.7
62.6 years
STANDARD_DEVIATION 9.53
59.71 years
STANDARD_DEVIATION 9.21
Region of Enrollment
Taiwan
2 participants5 participants7 participants
Sex: Female, Male
Female
1 Participants1 Participants2 Participants
Sex: Female, Male
Male
1 Participants4 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 50 / 11
serious
Total, serious adverse events
0 / 50 / 11

Outcome results

Primary

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.

Time frame: two years

Population: for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.

ArmMeasureValue (NUMBER)
Normal Parcipitants With Subclavian StealChange of Subclavian Flow to Normal Flow Pattern During Cuff Test0 participants
Hemodialytic Patients With Subclavian StealChange of Subclavian Flow to Normal Flow Pattern During Cuff Test2 participants
Primary

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.

Time frame: two year

Population: determined as above explained

ArmMeasureValue (NUMBER)
Normal Parcipitants With Subclavian StealChange of Vertebral Flow to Normal Flow Pattern During Cuff Test0 participants
Hemodialytic Patients With Subclavian StealChange of Vertebral Flow to Normal Flow Pattern During Cuff Test2 participants
Primary

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.

Time frame: one year

Population: for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.

ArmMeasureValue (NUMBER)
Normal Parcipitants With Subclavian Stealno Change of Subclavian Arterial Flow During Cuff Test5 participants
Hemodialytic Patients With Subclavian Stealno Change of Subclavian Arterial Flow During Cuff Test0 participants
Primary

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.

Time frame: 2 years

Population: as above explained

ArmMeasureValue (NUMBER)
Normal Parcipitants With Subclavian Stealno Change of Vertebral Arterial Flow During Cuff Test5 participants
Hemodialytic Patients With Subclavian Stealno Change of Vertebral Arterial Flow During Cuff Test0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026