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Adverse Reactions to MR and CT-examinations (Enhanced and Unenhanced)

NCT01132339 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1467

Last updated 2014-01-28

No results posted yet for this study

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.

Conditions

  • Renal Adverse Events - Contrast Induced Nephropathy (CIN)
  • Non-renal Adverse Events

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    lead OTHER

Principal Investigators

  • Manal Azzouz, MSc Pharmacy · Department of Diagnostic Radiology,Copenhagen University Hospital Herlev

  • Henrik S Thomsen · Department of Diagnostic Radiology,Copenhagen University Hospital Herlev

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-12-31
Completion
2013-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01132339 on ClinicalTrials.gov