Subclavian StealNCT01263301

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

A study testing carotid duplex in people with Subclavian Steal, run by Mennonite Christian Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Subclavian Steal
What is being tested?: carotid duplex
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteTaiwan
Study dates: Aug 2010to Jul 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

patients who revealed subclavian steal in the duplex study

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Mennonite Christial Hospital
Hualien City, Taiwan, 970

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions: Subclavian Steal
Being tested: carotid duplex
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
Medical subject headings: Subclavian Steal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01263301
Study group	Role	What they receive
carotid duplex for hemolytic patients wtih SSS	Active comparator	assigned intervention:carotid duplex Receives: Device: carotid duplex
carotid duplex for nonhemolytic patients with SSS	Active comparator	Not described Receives: Device: carotid duplex

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jul 2011

First posted20 Dec 2010 (estimated)
Study startAug 2010
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Subclavian StealStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01263301
Sponsor's protocol ID: 10-06-024-ER
Status last verified: Feb 2013
First submitted: 16 Dec 2010
Last updated: 12 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Differential Diagnosis for the Causes of Subclavian Steal for Patients With Vascular Access in the Forearm
ClinicalTrials.gov ID: NCT01263301
Acronym / sponsor ID: 10-06-024-ER
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Mennonite Christian HospitalUniversity, hospital or other
Study start: Aug 2010
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 20 Dec 2010 (estimated)
Results: Posted 1 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
carotid duplex for hemolytic patients wtih SSS	Active comparator	Device: carotid duplexassigned intervention:carotid duplex
carotid duplex for nonhemolytic patients with SSS	Active comparator	Device: carotid duplex

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

patients who revealed subclavian steal in the duplex study

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
carotid duplexAlso: steal syndromeCarotid duplex in the differential diagnosis of subclavian steal syndrome due to Arteriovenous Hemodialysis access in the Ipsilateral arm	Device	carotid duplex for hemolytic patients wtih SSS, carotid duplex for nonhemolytic patients with SSS

Primary outcome

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.
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.
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.
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.

Results and safety

Results posted to the registry on 1 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carotid Duplex for Nonhemidialytic Patients Wtih SSS	5	5
Carotid Duplex for Hemodialytic Patients	11	11

Primary outcome: Change of Subclavian Flow to Normal Flow Pattern During Cuff Test

Time frame: two years. Number. Unit: participants

Measure	Normal Parcipitants With Subclavian Steal n = 5	Hemodialytic Patients With Subclavian Steal n = 2
Value	0	2

Population analysed: 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.

Primary outcome: no Change of Subclavian Arterial Flow During Cuff Test

Time frame: one year. Number. Unit: participants

Measure	Normal Parcipitants With Subclavian Steal n = 5	Hemodialytic Patients With Subclavian Steal n = 2
Value	5	0

Primary outcome: Change of Vertebral Flow to Normal Flow Pattern During Cuff Test

Time frame: two year. Number. Unit: participants

Measure	Normal Parcipitants With Subclavian Steal n = 5	Hemodialytic Patients With Subclavian Steal n = 2
Value	0	2

Population analysed: determined as above explained

Primary outcome: no Change of Vertebral Arterial Flow During Cuff Test

Time frame: 2 years. Number. Unit: participants

Measure	Normal Parcipitants With Subclavian Steal n = 5	Hemodialytic Patients With Subclavian Steal n = 2
Value	5	0

Population analysed: as above explained

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carotid Duplex for Nonhemodialytic Patients Wtih SSS	0 of 5 (0%)	0 of 5 (0%)	Not reported
Carotid Duplex for Hemodialytic Patients With SSS	0 of 11 (0%)	0 of 11 (0%)	Not reported

Limitations and caveats (from the sponsor): the number of the study is small, no standard technique for measurement of blood flow of vascular access

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

lingchih wu principal investigator

Mennonite Christian Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing carotid duplex in people with Subclavian Steal, run by Mennonite Christian Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Subclavian Flow to Normal Flow Pattern During Cuff Test (time frame: two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01263301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.