Effects on the Diagnostic Accuracy of Magnetic Imaging Angiographies of the Supra-Aortic Vessels by Three Different Magnetic Resonance Contrast Agents in Patients

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00132223
• Other study ID #: 0710/2004-IKR
• Status: Recruiting
• Phase: Phase 4
• First received: August 18, 2005
• Last updated: April 11, 2006
• Start date: April 2005
• Est. completion date: December 2005

Study information

• Verified date: April 2006
• Source: University Hospital Muenster
• Contact: Boris Buerke, MD
• Phone: 00492518345123
• Email: buerkeb[@]uni-muenster.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Headache

• Epilepsia

• Dizziness

Exclusion Criteria:

• Pregnancy

• Metal implants (e.g. pacemaker)

• Contraindication for contrast agent

• Multiple allergies

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dizziness
• Epilepsy
• Headache
• Vertigo

Intervention

Drug:
• Contrast agent

Locations

Country	Name	City	State
Germany	University of Muenster, Dept. of Clinical Radiology	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intensity of vessels, muscle, air
Secondary	signal/noise ratio
Secondary	contrast/nose ratio