A DOUBLE-BLIND INTER-INDIVIDUAL COMPARISON OF IOMEPROL 300 AND IOMEPROL 400 IN MULTI-DETECTOR CT ANGIOGRAPHY (MDCTA) OF PERIPHERAL ARTERIES

• Conditions: Medical condition: indication for computed tomographic angiography of the peripheral arteries, in particular for diagnosis of peripheral arterial disease

• Registration Number: EUCTR2005-005946-38-DE
• Lead Sponsor: Bracco ALTANA Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-27
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

- Indication for Computed Tomographic Angiography (CTA)
- Patient is adult (age = 18 years), conscious and co-operative
- Written Informed Consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Known aortic aneurysm
- Major endoprosthesis, which could bias the diagnostic accuracy of MDCTA
- Hyperthyroidism (TSH below 0.3 mU/L)
- Renal insufficiency (serum creatinine > 1.5 mg/dL)
- Hypersensitivity to iodinated contrast media or significant allergic disposition
- Insulin-dependent diabetes mellitus, or metformin medication (discontinuation for 48 h enables CT examination of patients with normal renal function)
- Known pheochromocytoma or paraproteinaemia
- Acute stroke or cerebral oedema
- Known Epilepsy; currently active
- Planned radioactive iodine therapy
- Participation in a clinical trial within the past 30 days
- Previous participation in this clinical trial
- Alcohol or drug abuse
- Patient is female and pregnant or nursing
- Patient is female and the possibility of pregnancy cannot be excluded from one of the following points:
· surgical sterilization (method has to be recorded on medical history form)
· confirmed post-menopausal (with minimum 1-year history without menstruation)
· negative pregnancy test (confirmed via ß-HCG measurement)

- Patient is institutionalized by law
- Circumstances that would significantly decrease the chance of obtaining reliable data or of achieving the study objectives according to the Investigator’s final opinion
- Peripheral vein conditions, which would not allow for the required fast administration of contrast agents (18 gauge needle)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified