Chronic Cerebrospinal Venous InsufficiencyNCT01425554
Doppler Sonography, MR Venography, Plethysmography for the Diagnosis of CCSVI
A study testing Doppler sonography of internal jugular veins, Magnetic resonance venography of internal jugular veins and Air-plethysmography of the neck in people with Chronic Cerebrospinal Venous Insufficiency, run by Euromedic Specialist Clinics, Poland at 1 site in Poland.
Trial summary
This study is aimed at evaluation of diagnostic value of Doppler sonography, MR venography and air-plethysmography for the assessment of abnormalities in the internal jugular veins, with catheter venography as the reference test. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Cerebrospinal Venous Insufficiency
- What is being tested?
- Doppler sonography of internal jugular veins, Magnetic resonance venography of internal jugular veins and Air-plethysmography of the neck
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of multiple sclerosis
- none
Who cannot join
- coexisting another neurologic pathology (e.g. stroke, Parkinson disease)
- significant stenosis of carotid or vertebral arteries
- other significant abnormalities of blood vessels of the upper part of the body
- tricuspid valve incompetence
- allergy to iodine contrast dye
- chronic renal failure
Show all 14Show fewer
- pregnancy
- other severe comorbidities or significant abnormalities in standard lab tests
- Healthy volunteers.
- confirmed diagnosis of multiple sclerosis or related pathologies (CIS, NMO)
- coexisting another neurologic pathology (e.g. stroke, Parkinson disease)
- significant stenosis of carotid or vertebral arteries
- other significant abnormalities of blood vessels of the upper part of the body
- tricuspid valve incompetence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Doppler Sonography, Magnetic Resonance Venography, Air-plethysmography in the Non-invasive Diagnostics of Chronic Cerebrospinal Venous Insufficiency (CCSVI)
This study is aimed at evaluation of diagnostic value of Doppler sonography, MR venography and air-plethysmography for the assessment of abnormalities in the internal jugular veins, with catheter venography as the reference test.
- Being tested
- Doppler sonography of internal jugular veins, Magnetic resonance venography of internal jugular veins, Air-plethysmography of the neck, Catheter venography of internal jugular veins
- Keywords
- Vascular malformations in the internal jugular veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler sonography of internal jugular veinsOther
Doppler sonography of internal jugular veins
Magnetic resonance venography of internal jugular veinsOther
Magnetic resonance venography of internal jugular veins
Air-plethysmography of the neckOther
Air-plethysmography of the neck
Catheter venography of internal jugular veinsOther
Catheter venography of internal jugular veins
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic study | No intervention | Not described Receives: Other: Doppler sonography of internal jugular veins; Other: Magnetic resonance venography of internal jugular veins; Other: Air-plethysmography of the neck; Other: Catheter venography of internal jugular veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative predictive value of Doppler sonography, MR venography and air-plethysmography
Positive and negative predictive value of Doppler sonography,MR venography and air-plethysmography for the detecting of vascular malformation in the internal jugular veins with catheter venography as the reference test
Measured: All non-invasive test are done up to 14 days prior to catheter venography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cerebrospinal Venous InsufficiencyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Euromedic Specialist Clinics, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian Simka, Euromedic Specialist Clinics, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425554
- Sponsor's protocol ID
- 20/2011
- Status last verified
- Feb 2015
- First submitted
- 28 Aug 2011
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Sonography, Magnetic Resonance Venography, Air-plethysmography in the Non-invasive Diagnostics of Chronic Cerebrospinal Venous Insufficiency (CCSVI)
- ClinicalTrials.gov ID
- NCT01425554
- Acronym / sponsor ID
- 20/2011
- Keywords
- Vascular malformations in the internal jugular veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Euromedic Specialist Clinics, PolandUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed at evaluation of diagnostic value of Doppler sonography, MR venography and air-plethysmography for the assessment of abnormalities in the internal jugular veins, with catheter venography as the reference test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic study | No intervention | Other: Doppler sonography of internal jugular veins, Other: Magnetic resonance venography of internal jugular veins, Other: Air-plethysmography of the neck, Other: Catheter venography of internal jugular veins |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- none
Key exclusion criteria (14 listed)
- Healthy volunteers.
- confirmed diagnosis of multiple sclerosis or related pathologies (CIS, NMO)
- coexisting another neurologic pathology (e.g. stroke, Parkinson disease)
- significant stenosis of carotid or vertebral arteries
- other significant abnormalities of blood vessels of the upper part of the body
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 |
|---|---|---|
| Doppler sonography of internal jugular veinsDoppler sonography of internal jugular veins | Other | Diagnostic study |
| Magnetic resonance venography of internal jugular veinsMagnetic resonance venography of internal jugular veins | Other | Diagnostic study |
| Air-plethysmography of the neckAir-plethysmography of the neck | Other | Diagnostic study |
| Catheter venography of internal jugular veinsCatheter venography of internal jugular veins | Other | Diagnostic study |
Primary outcome
Positive and negative predictive value of Doppler sonography, MR venography and air-plethysmography
Time frame: All non-invasive test are done up to 14 days prior to catheter venography
Positive and negative predictive value of Doppler sonography,MR venography and air-plethysmography for the detecting of vascular malformation in the internal jugular veins with catheter venography as the reference test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler sonography of internal jugular veins, Magnetic resonance venography of internal jugular veins and Air-plethysmography of the neck in people with Chronic Cerebrospinal Venous Insufficiency, run by Euromedic Specialist Clinics, Poland at 1 site in Poland.
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 2 inclusion and 14 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 10 Feb 2015. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive and negative predictive value of Doppler sonography, MR venography and air-plethysmography (time frame: All non-invasive test are done up to 14 days prior to catheter venography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2015.