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    Clinical Trial Results:
    Minimizing contrast agent in computed tomography pulmonary angiography

    Summary
    EudraCT number
    		 2015-004657-40
    Trial protocol
    		 SE  
    Global end of trial date
    01 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2021
    First version publication date
    02 Dec 2021
    Other versions
    Summary report(s)
    		 CTPA2015 report abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    CTPA-2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Region Örebro län
    Sponsor organisation address
    Universitetssjukhuset Örebro, Örebro, Sweden,
    Public contact
    Mats Lidén, Region Örebro län, +46 196020370, mats.liden@regionorebrolan.se
    Scientific contact
    Mats Lidén, Region Örebro län, +46 196020370, mats.liden@regionorebrolan.se
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To develop and evaluate a computed tomography protocol for ruling out pulmonary embolism using a minimal amount of contrast medium.
    Protection of trial subjects
    All contrast media utilization for subjects in the study followed national and European guidelines for use of iodinated contrast media in computed tomography.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Sep 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 55
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    14
    From 65 to 84 years
    40
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with planned contrast media enhanced chest CT at the study site were screened for participation and 55 participants were included in this single arm study.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Single arm
    Arm description
    		 Development and evaluation of contrast media protocol
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omnipaque
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Single dosage corresponding to up to 80 mg iodine/ kg body weight. Maximum total dosage in study was 20 mL Omnipaque 350 mg/mL.

    Number of subjects in period 1
    		Single arm
    Started
    55
    Completed
    55

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 55 55
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 14 14
        From 65-84 years
    		 40 40
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 30 30
        Male
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 Development and evaluation of contrast media protocol

    Primary: Image quality

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    End point title
    		 Image quality [1]
    End point description
    Subjective image quality considering pulmonary embolism.
    End point type
    Primary
    End point timeframe
    The image quality was independently assessed by three blinded readers in a separate reading.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis was the proportion of images with at least adequate image quality, with no comparison groups.
    End point values
    		 Single arm
    Number of subjects analysed
    55
    Units: numbers
        Good-excellent
    44
        Adequate
    3
        Non-diagnostic
    0
        Not evaluated
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Any acute adverse events following contrast media administration were identified before the participant left the radiology department.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not used
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no adverse events encountered.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Mar 2017
    Change in inclusion criteria.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32436788
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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