HeadachePhase 4NCT00132223
Effects on the Diagnostic Accuracy of Magnetic Imaging Angiographies of the Supra-Aortic Vessels by Three Different Magnetic Resonance Contrast Agents in Patients
A Phase 4 study testing Contrast agent in people with Headache and Epilepsy, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Angiographies of the supra-aortic vessels by magnetic imaging have become common recently. So it was the purpose of this study to evaluate the imaging potential of different contrast agents. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Contrast agent
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2005to Dec 2005
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Headache
- Epilepsia
- Dizziness
Who cannot join
- Pregnancy
- Metal implants (e.g. pacemaker)
- Contraindication for contrast agent
- Multiple allergies
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Muenster, Dept. of Clinical Radiology
Münster, 48129
Boris Buerke, MD, 00492518345123, buerkeb@uni-muenster.de
Bernd Tombach, 00492518345123, tombach@uni-muenster.de
About this study
Official title: Effects on the Diagnostic Accuracy of Magnetic Imaging Angiographies of the Supra-Aortic Vessels by Three Different Magnetic Resonance Contrast Agents in Patients With Headache and Dizziness or Epilepsy and Clinical Indication for an Angiography by Magnetic Imaging
Angiographies of the supra-aortic vessels by magnetic imaging have become common recently. So it was the purpose of this study to evaluate the imaging potential of different contrast agents.
Three contrast agents for magnetic resonance imaging are compared in angiographies of the supra-aortic arteries in a intraindividual study of 10 patients.
Read more
All applications of these contrast agents are performed with a flow of 2 ml/s. One contrast medium is applicated a second time with a reduced flow of 1 ml/s.
The angiographies of the supra-aortic vessels are evaluated by two experienced readers in a consensus reading. The signal/noise- and contrast/noise-ratio of anatomic vessel segments of the carotic and vertebral arteries are measured and compared to each other.
- Being tested
- Contrast agent
- Keywords
- magnetic imaging, angiography, contrast agent, signal/noise ratio, contrast/noise ratio, vessel
- Medical subject headings
- Headache, Epilepsy, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast agentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
intensity of vessels, muscle, air
Secondary outcomes (2)
signal/noise ratio
contrast/nose ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startApr 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Bernd Tombach, MD, Study chair, University of Muenster, Dept. of Clinical Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132223
- Sponsor's protocol ID
- 0710/2004-IKR
- Status last verified
- Apr 2006
- First submitted
- 18 Aug 2005
- Last updated
- 12 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on the Diagnostic Accuracy of Magnetic Imaging Angiographies of the Supra-Aortic Vessels by Three Different Magnetic Resonance Contrast Agents in Patients With Headache and Dizziness or Epilepsy and Clinical Indication for an Angiography by Magnetic Imaging
- ClinicalTrials.gov ID
- NCT00132223
- Acronym / sponsor ID
- 0710/2004-IKR
- Keywords
- magnetic imaging, angiography, contrast agent, signal/noise ratio, contrast/noise ratio, vessel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Dec 2005
- First posted
- 19 Aug 2005 (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.
Angiographies of the supra-aortic vessels by magnetic imaging have become common recently. So it was the purpose of this study to evaluate the imaging potential of different contrast agents.
Three contrast agents for magnetic resonance imaging are compared in angiographies of the supra-aortic arteries in a intraindividual study of 10 patients.
All applications of these contrast agents are performed with a flow of 2 ml/s. One contrast medium is applicated a second time with a reduced flow of 1 ml/s.
The angiographies of the supra-aortic vessels are evaluated by two experienced readers in a consensus reading. The signal/noise- and contrast/noise-ratio of anatomic vessel segments of the carotic and vertebral arteries are measured and compared to each other.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Headache
- Epilepsia
- Dizziness
Key exclusion criteria (4 listed)
- Pregnancy
- Metal implants (e.g. pacemaker)
- Contraindication for contrast agent
- Multiple allergies
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 |
|---|---|---|
| Contrast agent | Drug | – |
Primary outcome
intensity of vessels, muscle, air
2 secondary outcomes
signal/noise ratio
contrast/nose ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2006.
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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.
Bernd Tombach, MD study chair
University of Muenster, Dept. of Clinical Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contrast agent in people with Headache and Epilepsy, run by University Hospital Muenster at 1 site in Germany.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Apr 2006. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris Buerke, MD (00492518345123, buerkeb@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensity of vessels, muscle, air. 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 12 Apr 2006.