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    Clinical Trial Results:
    Magnetic Resonance Imaging Using Ultrasmall Superparamagnetic Particles of Iron Oxide in Patients Under Surveillance for Abdominal Aortic Aneurysms to Predict Rupture or Surgical Repair: the MA3RS Trial

    Summary
    EudraCT number
    2012-002448-25
    Trial protocol
    GB  
    Global end of trial date
    01 Nov 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    30 May 2019
    First version publication date
    30 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MA3RS Trial
    Additional study identifiers
    ISRCTN number
    ISRCTN76413758
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    The University of Edinburgh
    Sponsor organisation address
    Old College, South Bridge, Edinburgh, United Kingdom, EH8 9YL
    Public contact
    Professor David Newby, The University of Edinburgh, +44 0131 242 6515 , d.e.newby@ed.ac.uk
    Scientific contact
    Professor David Newby, The University of Edinburgh, +44 0131 242 6515 , d.e.newby@ed.ac.uk
    Sponsor organisation name
    Lothian Health Board
    Sponsor organisation address
    Waverley Gate, 2-4 Waterloo Place, Edinburgh, United Kingdom, EH1 3EG
    Public contact
    Professor David Newby, The University of Edinburgh, +44 0131 242 6515 , d.e.newby@ed.ac.uk
    Scientific contact
    Professor David Newby, The University of Edinburgh, +44 0131 242 6515 , d.e.newby@ed.ac.uk
    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
    14 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    An abdominal aortic aneurysm is a swelling of the main blood vessel that supplies the organs in the abdomen and the legs. It most commonly occurs just below the kidneys (approximately at the level of the belly button). It is not yet clear why some people develop aneurysms but they are more common in smokers and in men. Abdominal aortic aneurysms are dangerous because they can rupture and if this happens up to 90% of people affected will die. Of those who make it to hospital, they have a less than 50% chance of surviving. At present, we use size, measured by an ultrasound scan, to best predict which abdominal aortic aneurysms are most likely to rupture. The problem with this is that sometimes small abdominal aortic aneurysms rupture and large abdominal aortic aneurysms go on to grow to 10cm without rupturing. This suggests that size is not the only factor to cause abdominal aortic aneurysms to grow and rupture. The principal objective of this study is to use magnetic resonance
    Protection of trial subjects
    None
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 342
    Worldwide total number of subjects
    342
    EEA total number of subjects
    342
    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)
    115
    From 65 to 84 years
    227
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment was across 3 sites in Scotland, UK. Recruitment opened in November 2012 and closed in December 2014. There was a temporary halt on recruitment between July 2014 and September 2014 after an urgent update to administration guidelines of study drug

    Pre-assignment
    Screening details
    Patients were identified from the surveillance service database and eligibility was assessed either at the surveillance ultrasound appointment or over the telephone. Eligibility was confirmed before consent was taken.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    All patients
    Arm description
    All patients recruited
    Arm type
    Experimental

    Investigational medicinal product name
    Ferumoxytol
    Investigational medicinal product code
    NA
    Other name
    NA
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The single use vials are diluted and administered as an intravenous infusion over 15-30 minutes. The ferumoxytol dose (4.0 mg/kg) is diluted in sterile 0.9% sodium chloride up to a final concentration of 2-8 mg iron per mL.

    Number of subjects in period 1
    All patients
    Started
    342
    Completed
    342

    Baseline characteristics

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

    Reporting group values
    Baseline Total
    Number of subjects
    342 342
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    74.0 (53.0 to 91.0) -
    Gender categorical
    Units: Subjects
        Female
    50 50
        Male
    292 292
    Smoking Status
    Units: Subjects
        Current
    101 101
        Ex-smoker
    195 195
        Never
    46 46
    Alcohol intake
    Units: Subjects
        Missing
    2 2
        Yes
    134 134
        No
    206 206
    CIA
    Units: Subjects
        No
    276 276
        Right
    21 21
        Left
    10 10
        Both
    35 35
    Hypertension
    Units: Subjects
        Yes
    246 246
        No
    96 96
    Diabetes
    Units: Subjects
        Yes
    47 47
        No
    295 295
    Hypercholesterolaemia
    Units: Subjects
        Yes
    257 257
        No
    85 85
    IHD
    Units: Subjects
        No
    217 217
        Yes
    125 125
    Angina
    Units: Subjects
        Yes
    50 50
        No
    292 292
    MI
    Units: Subjects
        Yes
    92 92
        No
    250 250
    PCI
    Units: Subjects
        Yes
    34 34
        No
    308 308
    CABG
    Units: Subjects
        Yes
    42 42
        No
    300 300
    PVD
    Units: Subjects
        No
    276 276
        Yes
    66 66
    PVD - Claudication
    Units: Subjects
        Yes
    62 62
        No
    280 280
    PVD - rest pain
    Units: Subjects
        Yes
    2 2
        No
    340 340
    PVD - tissue loss
    Units: Subjects
        Yes
    2 2
        No
    340 340
    PVD - angioplasty
    Units: Subjects
        Yes
    11 11
        No
    331 331
    PVD - bypass
    Units: Subjects
        Yes
    8 8
        No
    334 334
    CVD
    Units: Subjects
        No
    296 296
        Yes
    46 46
    CD TIA
    Units: Subjects
        Yes
    28 28
        No
    314 314
    CD CVA
    Units: Subjects
        Yes
    19 19
        No
    323 323
    Family History of AAA
    Units: Subjects
        Yes
    61 61
        No
    281 281
    ACE-1
    Units: Subjects
        Yes
    123 123
        No
    219 219
    Anticoagulant
    Units: Subjects
        No
    317 317
        Yes
    25 25
    Antiplatlet
    Units: Subjects
        Yes
    224 224
        No
    118 118
    Beta blocker
    Units: Subjects
        Yes
    120 120
        No
    222 222
    Statin
    Units: Subjects
        No
    72 72
        Yes
    270 270
    Subject analysis sets

    Subject analysis set title
    All participants
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Consented patients who were non-withdrawn during baseline assessment phase

    Subject analysis sets values
    All participants
    Number of subjects
    342
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    74.0 (53.0 to 91.0)
    Gender categorical
    Units: Subjects
        Female
    50
        Male
    292
    Smoking Status
    Units: Subjects
        Current
    101
        Ex-smoker
    195
        Never
    46
    Alcohol intake
    Units: Subjects
        Missing
    2
        Yes
    134
        No
    206
    CIA
    Units: Subjects
        No
    276
        Right
    21
        Left
    10
        Both
    35
    Hypertension
    Units: Subjects
        Yes
    246
        No
    96
    Diabetes
    Units: Subjects
        Yes
    47
        No
    295
    Hypercholesterolaemia
    Units: Subjects
        Yes
    257
        No
    85
    IHD
    Units: Subjects
        No
    217
        Yes
    125
    Angina
    Units: Subjects
        Yes
    50
        No
    292
    MI
    Units: Subjects
        Yes
    92
        No
    250
    PCI
    Units: Subjects
        Yes
    34
        No
    308
    CABG
    Units: Subjects
        Yes
    42
        No
    300
    PVD
    Units: Subjects
        No
    276
        Yes
    66
    PVD - Claudication
    Units: Subjects
        Yes
    62
        No
    280
    PVD - rest pain
    Units: Subjects
        Yes
    2
        No
    340
    PVD - tissue loss
    Units: Subjects
        Yes
    2
        No
    340
    PVD - angioplasty
    Units: Subjects
        Yes
    11
        No
    331
    PVD - bypass
    Units: Subjects
        Yes
    8
        No
    334
    CVD
    Units: Subjects
        No
    296
        Yes
    46
    CD TIA
    Units: Subjects
        Yes
    28
        No
    314
    CD CVA
    Units: Subjects
        Yes
    19
        No
    323
    Family History of AAA
    Units: Subjects
        Yes
    61
        No
    281
    ACE-1
    Units: Subjects
        Yes
    123
        No
    219
    Anticoagulant
    Units: Subjects
        No
    317
        Yes
    25
    Antiplatlet
    Units: Subjects
        Yes
    224
        No
    118
    Beta blocker
    Units: Subjects
        Yes
    120
        No
    222
    Statin
    Units: Subjects
        No
    72
        Yes
    270

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    All patients recruited

    Subject analysis set title
    All participants
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Consented patients who were non-withdrawn during baseline assessment phase

    Primary: AAA Rupture and Repair

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    End point title
    AAA Rupture and Repair [1]
    End point description
    Number of days between consent and rupture, where no rupture or repair has occurred participants have been censored at 21st November 2016 or date of death
    End point type
    Primary
    End point timeframe
    Start date - 21st November 2016
    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: There was no statistical analyses for this end point
    End point values
    All participants
    Number of subjects analysed
    342
    Units: Number of events
    140
    No statistical analyses for this end point

    Primary: AAA Repair

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    End point title
    AAA Repair [2]
    End point description
    Time to event has been determined by the number of days between consent and repair, where no repair has occurred participants have been censored at 21st November or at date of death
    End point type
    Primary
    End point timeframe
    Start date - 21st November 2016
    Notes
    [2] - 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: There was no statistical analyses for this primary end point
    End point values
    All participants
    Number of subjects analysed
    Units: Number of events
    126
    No statistical analyses for this end point

    Primary: AAA Rupture

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    End point title
    AAA Rupture [3]
    End point description
    Time to event has been determined by the number of days between consent and rupture, where no rupture has occurred participants have been censored at 21st November 2016 or date of death
    End point type
    Primary
    End point timeframe
    Start date - 21st November 2016
    Notes
    [3] - 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: There was no statistical analyses for this primary end point
    End point values
    All participants
    Number of subjects analysed
    Units: Number of events
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Date participant signs the consent form to last trial follow-up visit
    Adverse event reporting additional description
    Trial nurses asked participants about AEs during follow-up visits and details of all events were recorded on the trial AE logs
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    All consented participants
    Reporting group description
    All participants who have given consent for the trial are included in this group

    Serious adverse events
    All consented participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    163 / 342 (47.66%)
         number of deaths (all causes)
    48
         number of deaths resulting from adverse events
    33
    Vascular disorders
    Any vascular disorder
         subjects affected / exposed
    9 / 342 (2.63%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    Surgical and medical procedures
    Any surgical and medical procedure
         subjects affected / exposed
    20 / 342 (5.85%)
         occurrences causally related to treatment / all
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    any neoplasms benign, malignant and unspecified
         subjects affected / exposed
    21 / 342 (6.14%)
         occurrences causally related to treatment / all
    0 / 22
         deaths causally related to treatment / all
    0 / 8
    General disorders and administration site conditions
    Any general disorders and administration site conditions
         subjects affected / exposed
    15 / 342 (4.39%)
         occurrences causally related to treatment / all
    0 / 16
         deaths causally related to treatment / all
    0 / 8
    Reproductive system and breast disorders
    Any reproductive system and breast disorders
         subjects affected / exposed
    3 / 342 (0.88%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    any injury, poisoning and procedural complications
         subjects affected / exposed
    10 / 342 (2.92%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Any investigations
         subjects affected / exposed
    2 / 342 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Any cardiac disorder
         subjects affected / exposed
    16 / 342 (4.68%)
         occurrences causally related to treatment / all
    0 / 18
         deaths causally related to treatment / all
    0 / 7
    Respiratory, thoracic and mediastinal disorders
    Any respiratory, thoracic and mediastinal disorder
         subjects affected / exposed
    4 / 342 (1.17%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Any nervous system disorder
         subjects affected / exposed
    8 / 342 (2.34%)
         occurrences causally related to treatment / all
    0 / 11
         deaths causally related to treatment / all
    0 / 2
    Gastrointestinal disorders
    Any gastrointestinal disorder
         subjects affected / exposed
    11 / 342 (3.22%)
         occurrences causally related to treatment / all
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Any renal and urinary disorders
         subjects affected / exposed
    5 / 342 (1.46%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Any hepatobiliary disorders
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Any musculoskeletal and connective tissue disorders
         subjects affected / exposed
    5 / 342 (1.46%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Any metabolism and nutrition disorder
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Any infections and infestations
         subjects affected / exposed
    32 / 342 (9.36%)
         occurrences causally related to treatment / all
    0 / 38
         deaths causally related to treatment / all
    0 / 5
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    All consented participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    184 / 342 (53.80%)
    Vascular disorders
    Any vascular disorder
         subjects affected / exposed
    11 / 342 (3.22%)
         occurrences all number
    11
    Surgical and medical procedures
    Any surgical and medical procedure
         subjects affected / exposed
    28 / 342 (8.19%)
         occurrences all number
    31
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Any neoplasms benign, malignant and unspecified
         subjects affected / exposed
    23 / 342 (6.73%)
         occurrences all number
    24
    General disorders and administration site conditions
    Any general disorder and administration site condition
         subjects affected / exposed
    11 / 342 (3.22%)
         occurrences all number
    12
    Injury, poisoning and procedural complications
    Any injury, poisoning and procedural complication
         subjects affected / exposed
    23 / 342 (6.73%)
         occurrences all number
    24
    Investigations
    Any investigation
         subjects affected / exposed
    25 / 342 (7.31%)
         occurrences all number
    25
    Cardiac disorders
    Any cardiac disorders
         subjects affected / exposed
    20 / 342 (5.85%)
         occurrences all number
    21
    Respiratory, thoracic and mediastinal disorders
    Any respiratory, thoracic and mediastinal disorder
         subjects affected / exposed
    16 / 342 (4.68%)
         occurrences all number
    19
    Blood and lymphatic system disorders
    Any blood and lymphatic system disorder
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences all number
    1
    Nervous system disorders
    Any nervous system disorder
         subjects affected / exposed
    13 / 342 (3.80%)
         occurrences all number
    16
    Eye disorders
    Any eye disorder
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences all number
    1
    Gastrointestinal disorders
    Any gastrointestinal disorders
         subjects affected / exposed
    27 / 342 (7.89%)
         occurrences all number
    30
    Renal and urinary disorders
    Any renal and urinary disorder
         subjects affected / exposed
    4 / 342 (1.17%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Any skin and subcutaneous tissue disorders
         subjects affected / exposed
    2 / 342 (0.58%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Any musculoskeletal and connective tissue disorder
         subjects affected / exposed
    16 / 342 (4.68%)
         occurrences all number
    17
    Endocrine disorders
    Any endocrine disorders
         subjects affected / exposed
    1 / 342 (0.29%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Any metabolism and nutrition disorder
         subjects affected / exposed
    3 / 342 (0.88%)
         occurrences all number
    3
    Infections and infestations
    Any infection and and infestation
         subjects affected / exposed
    53 / 342 (15.50%)
         occurrences all number
    60

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    NA
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