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    Clinical Trial Results:
    68Ga-NODAGA-RGD cardiac PET in patients with acute myocardial infarction or chronic total coronary occlusion

    Summary
    EudraCT number
    		 2014-004392-23
    Trial protocol
    		 FI  
    Global end of trial date
    11 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jan 2025
    First version publication date
    08 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    T189/2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04871217
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Turku University Hospital
    Sponsor organisation address
    Kiinamyllynkatu 4-8, Turku, Finland, 20520
    Public contact
    Turku University Hospital, Heart Center, Turku University Hospital, +358 23130083, antti.saraste@utu.fi
    Scientific contact
    Turku University Hospital, Heart Center, Turku University Hospital, +358 23130083, antti.saraste@utu.fi
    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
    16 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate PET imaging with 68Ga-NODAGA-RGD in patients with acute or chronic coronary artery occlusion
    Protection of trial subjects
    None
    Background therapy
    		 Guideline directed medical therapy of acute myocardial infarction/chronic coronary artery disease
    Evidence for comparator
    		 None
    Actual start date of recruitment
    31 Jan 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    12
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Prospective recruitment of patients with first ST-elevation acute myocardial infarction from December 2018 to January 2021 in Turku University Hospital, Finland.

    Pre-assignment
    Screening details
    		 Patients with first ST-elevation acute myocardial infarction were screened.

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

    Arms
    Arm title
    		 Single arm
    Arm description
    		 Cardiac PET scan after injection of [68Ga]Ga-NODAGA-RGD
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-NODAGA-RGD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    An average of 179 +/- 15 MBq of 68Ga-NODAGA-RGD was injected as an intravenous bolus.

    Number of subjects in period 1
    		Single arm
    Started
    31
    Completed
    31

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 31 31
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64 ( 9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 28 28

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 Cardiac PET scan after injection of [68Ga]Ga-NODAGA-RGD

    Primary: 68Ga-NODAGA-RGD uptake in myocardial area at risk

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    End point title
    		 68Ga-NODAGA-RGD uptake in myocardial area at risk [1]
    End point description
    Uptake of 68Ga-NODAGA-RGD in the myocardial area at risk was significantly higher than in the remote myocardium of the same patients (p<0.001).
    End point type
    Primary
    End point timeframe
    3-14 days after ST-elevation myocardial infarction
    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 end point was not compared between groups in this single arm study (explanation in end point definition section)
    End point values
    		 Single arm
    Number of subjects analysed
    31 [2]
    Units: SUV
        arithmetic mean (standard deviation)
    0.7 ( 0.2 )
    Notes
    [2] - Single arm trial
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    2 years from baseline (from Dec 2018 to Feb 2023)
    Adverse event reporting additional description
    Clinical evaluation (visits at baseline and at 6 months) and electronic medical records (2-year follow-up). Adverse events included death, myocardial infarction and heart failure hospitalization.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 -

    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: Only one (serious) adverse event in this small diagnostic trial
    Serious adverse events
    		 Single arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 31 (3.23%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Myocardial infarction
    Additional description: Non–ST-elevation acute myocardial infarction caused by a coronary lesion other than the index lesion 6 months after baseline. Unrelated to the investigational product.
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Single arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37973184
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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
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