Adverse Reactions to MR and CT-examinations (Enhanced and Unenhanced)
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|ClinicalTrials.gov Identifier: NCT01132339|
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : January 28, 2014
Contrast agents are important tools for MR/CT- examinations, when it comes to diagnosing diseases. But despite their frequent use in Denmark, they are not free of serious and potentially fatal adverse reactions. Examples of this are contrast-induced nephropathy (CIN) and nephrogenic systemic fibrosis (NSF). Therefore, it is extremely important to clarify if these adverse reactions are actually directly related to the use of contrast agents or to MR/CT- examinations.
To prospectively assess the incidence of adverse reactions of iodine-containing CT and gadolinium- based MR contrast agents in a prospective design. A control group examined without the use of contrast agent will be included, so that the study can illuminate reported adverse events related to contrast agents and CT/MR- examinations. This project will in the long term mean that, any significant and life-threatening delayed adverse reactions will be discovered earlier and hence it will be more likely to treat the patients in good time for these adverse reactions.
The following series of hypotheses will be investigated in this study:
- Renal as well as non-renal adverse reactions occurring are related to the use of contrast agent in MR-/CT-examination.
- CIN occurs in patients undergoing a MR-/CT-examination with contrast agent.
Approvals are obtained from The Copenhagen County Committee on Biomedical Research Ethics and Danish Data Protection Agency. A total of 1600 patients will be included from Department of Radiology at Herlev Hospital, where all the MR- and CT examinations will be performed. Patients will be divided into four groups (a, b, c and d) with 400 patients in each group. Group a and c (case group) undergo respectively MR and CT examination with contrast agent While group b and d (control group) will undergo respectively MR and CT examination without the use of contrast agent. For each patient the following will be recorded: Risk factors, renal function (eGFR) before and 72 hours after MR/CT- examination as well as the incidence of immediate reactions (within 30 min.). Furthermore, patients have to answer a questionnaire 72 hours and 1 month after MR/CT- examination about the severity and frequency of adverse reactions to contrast media.
|Condition or disease|
|Renal Adverse Events - Contrast Induced Nephropathy (CIN) Non-renal Adverse Events|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||1467 participants|
|Official Title:||Prospective Clinical Trial to Investigate Adverse Reactions to MR and CT-examinations (Enhanced and Unenhanced)|
|Study Start Date :||May 2010|
|Primary Completion Date :||December 2012|
|Study Completion Date :||October 2013|
Enhanced MR (case group)
those with an exposure to gadolinium-based contrast agent
Unenhanced MR (control group)
those without an exposure to gadolinium-based contrast agent
Unenhanced CT (control group)
those without an exposure to iodine-containing contrast agent
Enhanced CT (case group)
those with an exposure to iodine-containing contrast agent
- Renal and non-renal adverse events to enhanced and unenhanced CT and MRI [ Time Frame: before, 3 days and 1 month after enhanced or unenhanced CT and MRI ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132339
|Department of Diagnostic Radiology,Copenhagen University Hospital Herlev|
|Herlev, Denmark, 2730|
|Principal Investigator:||Manal Azzouz, MSc Pharmacy||Department of Diagnostic Radiology,Copenhagen University Hospital Herlev|
|Study Director:||Henrik S Thomsen||Department of Diagnostic Radiology,Copenhagen University Hospital Herlev|