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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01132339
First received: May 25, 2010
Last updated: January 25, 2014
Last verified: January 2014
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Clinical Trial to Investigate Adverse Reactions to MR and CT-examinations (Enhanced and Unenhanced)

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1467
Study Start Date: May 2010
Study Completion Date: October 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Additional 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
Study First Received: May 25, 2010
Last Updated: January 25, 2014
Health Authority: Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014