Clinical Trial Results:
68Ga-NODAGA-RGD cardiac PET in patients with acute myocardial infarction or chronic total coronary occlusion
Summary
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EudraCT number |
2014-004392-23 |
Trial protocol |
FI |
Global end of trial date |
11 Feb 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Jan 2025
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First version publication date |
08 Jan 2025
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
T189/2016
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04871217 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Turku University Hospital
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Sponsor organisation address |
Kiinamyllynkatu 4-8, Turku, Finland, 20520
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Public contact |
Turku University Hospital, Heart Center, Turku University Hospital, +358 23130083, antti.saraste@utu.fi
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Scientific contact |
Turku University Hospital, Heart Center, Turku University Hospital, +358 23130083, antti.saraste@utu.fi
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
16 Nov 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Feb 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Feb 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Evaluate PET imaging with 68Ga-NODAGA-RGD in patients with acute or chronic coronary artery occlusion
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Protection of trial subjects |
None
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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
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Scientific research | ||
Long term follow-up duration |
2 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Finland: 31
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Worldwide total number of subjects |
31
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EEA total number of subjects |
31
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
19
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85 years and over |
0
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Recruitment
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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
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Screening details |
Patients with first ST-elevation acute myocardial infarction were screened. | ||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Unblinded trial
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Arms
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Arm title
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Single arm | ||||||
Arm description |
Cardiac PET scan after injection of [68Ga]Ga-NODAGA-RGD | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
68Ga-NODAGA-RGD
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
An average of 179 +/- 15 MBq of 68Ga-NODAGA-RGD was injected as an intravenous bolus.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Single arm
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Reporting group description |
Cardiac PET scan after injection of [68Ga]Ga-NODAGA-RGD |
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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).
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End point type |
Primary
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End point timeframe |
3-14 days after ST-elevation myocardial infarction
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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) |
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Notes [2] - Single arm trial |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
2 years from baseline (from Dec 2018 to Feb 2023)
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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.
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Assessment type |
Non-systematic | ||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
21.0
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Reporting groups
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Reporting group title |
Single arm
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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 |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/37973184 |