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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01132339
Date of registration: 25/05/2010
Primary sponsor: Copenhagen University Hospital at Herlev
Public title: Adverse Reactions to MR and CT-examinations (Enhanced and Unenhanced)
Scientific title: Prospective Clinical Trial to Investigate Adverse Reactions to MR and CT-examinations (Enhanced and Unenhanced)
Date of first enrolment: May 2010
Target sample size: 1600
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01132339
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
Denmark
Contacts
Name:   Manal Azzouz, MSc Pharmacy
Address: 
Telephone: +45 44 88 43 91
Email: MAZZ0001@heh.regionh.dk
Affiliation: 
Name:   Manal Azzouz, MSc Pharmacy
Address: 
Telephone: +45 44 88 43 91
Email: MAZZ0001@heh.regionh.dk
Affiliation: 
Name:   Henrik S Thomsen
Address: 
Telephone:
Email:
Affiliation:  Department of Diagnostic Radiology,Copenhagen University Hospital Herlev
Name:   Manal Azzouz, MSc Pharmacy
Address: 
Telephone:
Email:
Affiliation:  Department of Diagnostic Radiology,Copenhagen University Hospital Herlev
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who are referred to a MR/CT-examination at Herlev Hospital, Department of
Radiology

- Age > 18 years

Exclusion Criteria:

- Age < 18 years

- Patients allergic to gadolinium-based and iodine-containing contrast agents are not
included in the case group

- Increased metabolism (hyperthyroidism)

- Dementia

- Pregnancy / lactation

- Patients who have undergone MR/CT- examinations within the last month prior to the
actual examination

- New MR/CT-examination (enhanced and unenhanced) in the observation period (one
month).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Contrast Induced Nephropathy
Nephrogenic Systemic Fibrosis
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
H-1-2010-011
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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