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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
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

Study Description
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Brief Summary:

Rationale:

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.

Objective:

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:

  1. Renal as well as non-renal adverse reactions occurring are related to the use of contrast agent in MR-/CT-examination.
  2. CIN occurs in patients undergoing a MR-/CT-examination with contrast agent.

Methods:

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

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Study Design
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Study Type : Observational
Actual Enrollment : 1467 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Clinical Trial to Investigate Adverse Reactions to MR and CT-examinations (Enhanced and Unenhanced)
Study Start Date : May 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : October 2013
Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population will be selected from Herlev Hospital, Department of Radiology. Patients referred to an MR/CT-examination will be offered participation in this study.
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
  • 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).
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Denmark
Department of Diagnostic Radiology,Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01132339     History of Changes
Other Study ID Numbers: H-1-2010-011
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014

Keywords provided by Copenhagen University Hospital at Herlev:
Adverse reactions to Gadolinium-based contrast agents.
Adverse reactions to Iodine-basedcontrast agents.