Acute Myocardial InfarctionPhase 2NCT03445884
68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Myocardial Angiogenesis
A Phase 2 study testing 68Ga-NODAGA-E[c(RGDyK)]2 in people with Acute Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with myocardial infarction and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- 68Ga-NODAGA-E[c(RGDyK)]2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2018to 1 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 50 years
- Acute myocardial infarction Group:
- Verified first-time acute myocardial infarction treated with PCI
- Control Group:
- Previous healthy
- No known cardiac disease
Who cannot join
- No prior history of acute coronary infarction
- No prior history of Heart surgery
- Not treated with anti-angiogenic medicine
- Subject with pacemaker, cochlear implant or insulin pump
- Pregnancy
- Lactation
Show all 12Show fewer
- Severe claustrophobia
- Severe obesity (weight above 140kg)
- If a subject is in the fertile age, a pregnancy test will be use prior to injection to the PET_tracer
- If a subject is having a severe allergic reaction to the PET-tracer, the person will be excluded for the rest of the trial
- If the PET-tracer is administered subcutaneous, the person will be excluded for the rest of the trial¨
- Tupe I or II diabetes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physiology, Nuclear Medicine and PET
Copenhagen, Capital Region, 2100
About this study
Official title: 68Ga-NODAGA-E[c(RGDγK)]2: a Novel Positron Emission Tomography (PET) Tracer for in Vivo Molecular Imaging of Myocardial Angiogenesis Following Myocardial Infarction
The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with myocardial infarction and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis.
Read the detailed description
Ischemic heart disease is worldwide the single most frequent cause of death. The number of patients surviving acute myocardial injury is increasing due to improved acute treatment. However, after the initial repair, the tissue undergoes a remodeling phase to compensate for the damaged area. This re-modeling phase can change the structure end geometry of the heart resulting in lower ejection fraction, leading to cardiac dysfunction, which eventually leads to heart failure. Understanding and ideally modifying the reparative mechanisms following myocardial infarction is increasingly important and may lead to improved outcome.
If the heart suffers from ischemia following an acute coronary event, the tissue reacts strongly to the hypoxia. The body will as a compensatory mechanism create new vessel to provide the tissue with oxygen. This is known as the biological process of angiogenesis. This complex process involves different angiogenic and pro-fibrotic transcription factors that initiate the restoration of capillaries by sprouting from the existing endothelial cells in response to hypoxia.
Time seem essential to protect and save the myocardium. An early onset of cytokines and growth factors is associated with a decline in cardiomyocytes apoptosis, smaller infarct areas, and decreased ventricular dilation. Therefore, an early induction of angiogenesis seems important for a good prognosis of the patient.
Integrin αvβ3 is a transmembrane cell surface receptor that is markedly upregulated in states of angiogenesis. It facilitates migration and proliferation and thereby allowing cells to respond to extracellular environment. Integrin αvβ3 is thus a key player in the angiogenic process. The integrin αvβ3 has a binding site for an RGD peptide (Arg-Gly-Asp motif) and this can be targeted by PET tracers.
RGD-based PET tracers have been shown to accumulate at the site of myocardial necrosis in both human and animal studies. The uptake seems to peak a few weeks after the infarction and may correlate to recovery of cardiac function and thus serve as a prognostic marker.
- Conditions
- Acute Myocardial Infarction
- Being tested
- 68Ga-NODAGA-E[c(RGDyK)]2
- Keywords
- positron emission tomography, nuclear medicine, prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-E[c(RGDyK)]2Drug
Also called RGD-PET
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
| Study group | Role | What they receive |
|---|---|---|
| Acute myocardial infarctions group | Experimental | 200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. three times. 1-3 days after intervention, 7-10 days after intervention and 30-35 days after intervention. Receives: Drug: 68Ga-NODAGA-E[c(RGDyK)]2 |
| Control group | Active comparator | 200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. one time. Receives: Drug: 68Ga-NODAGA-E[c(RGDyK)]2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate myocardial angiogenesis
Analysing uptake of 68Ga-NODAGA-E[c(RGDyK)]2 Positron Emission Tomography in myocardial infarction after PCI
Measured: 30-35 days
Secondary outcomes (3)
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion
Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and change in myocardial perfusion after PCI using Rubidium 82 Positron Emission Tomography after Percutaneous coronary intervention(PCI)
Measured: 30-35 days
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery
Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery using Magnetic Resonance after PCI
Measured: 30-35 days
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability
Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability using Flour-Deoxy-Glucose Positron Emission Tomography after PCI
Measured: 30-35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start20 Feb 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Bentsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Andreas Kjær, MD, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445884
- Sponsor's protocol ID
- EUDRACR-number: 2017-002709-36
- Status last verified
- Jul 2020
- First submitted
- 18 Feb 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-NODAGA-E[c(RGDγK)]2: a Novel Positron Emission Tomography (PET) Tracer for in Vivo Molecular Imaging of Myocardial Angiogenesis Following Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03445884
- Acronym / sponsor ID
- EUDRACR-number: 2017-002709-36
- Conditions
- Acute Myocardial Infarction
- Keywords
- positron emission tomography, nuclear medicine, prognosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with myocardial infarction and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis.
Detailed description
Ischemic heart disease is worldwide the single most frequent cause of death. The number of patients surviving acute myocardial injury is increasing due to improved acute treatment. However, after the initial repair, the tissue undergoes a remodeling phase to compensate for the damaged area. This re-modeling phase can change the structure end geometry of the heart resulting in lower ejection fraction, leading to cardiac dysfunction, which eventually leads to heart failure. Understanding and ideally modifying the reparative mechanisms following myocardial infarction is increasingly important and may lead to improved outcome.
If the heart suffers from ischemia following an acute coronary event, the tissue reacts strongly to the hypoxia. The body will as a compensatory mechanism create new vessel to provide the tissue with oxygen. This is known as the biological process of angiogenesis. This complex process involves different angiogenic and pro-fibrotic transcription factors that initiate the restoration of capillaries by sprouting from the existing endothelial cells in response to hypoxia.
Time seem essential to protect and save the myocardium. An early onset of cytokines and growth factors is associated with a decline in cardiomyocytes apoptosis, smaller infarct areas, and decreased ventricular dilation. Therefore, an early induction of angiogenesis seems important for a good prognosis of the patient.
Integrin αvβ3 is a transmembrane cell surface receptor that is markedly upregulated in states of angiogenesis. It facilitates migration and proliferation and thereby allowing cells to respond to extracellular environment. Integrin αvβ3 is thus a key player in the angiogenic process. The integrin αvβ3 has a binding site for an RGD peptide (Arg-Gly-Asp motif) and this can be targeted by PET tracers.
RGD-based PET tracers have been shown to accumulate at the site of myocardial necrosis in both human and animal studies. The uptake seems to peak a few weeks after the infarction and may correlate to recovery of cardiac function and thus serve as a prognostic marker.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute myocardial infarctions group | Experimental | Drug: 68Ga-NODAGA-E[c(RGDyK)]2200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. three times. 1-3 days after intervention, 7-10 days after intervention and 30-35 days after intervention. |
| Control group | Active comparator | Drug: 68Ga-NODAGA-E[c(RGDyK)]2200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. one time. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 50 years
- Verified first-time acute myocardial infarction treated with PCI
- Previous healthy
- No known cardiac disease
Key exclusion criteria (12 listed)
- No prior history of acute coronary infarction
- No prior history of Heart surgery
- Not treated with anti-angiogenic medicine
- Subject with pacemaker, cochlear implant or insulin pump
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NODAGA-E[c(RGDyK)]2Also: RGD-PET200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. | Drug | Acute myocardial infarctions group, Control group |
Primary outcome
To evaluate myocardial angiogenesis
Time frame: 30-35 days
Analysing uptake of 68Ga-NODAGA-E[c(RGDyK)]2 Positron Emission Tomography in myocardial infarction after PCI
3 secondary outcomes
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion
Time frame: 30-35 days
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery
Time frame: 30-35 days
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability
Time frame: 30-35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Kjær, MD study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-NODAGA-E[c(RGDyK)]2 in people with Acute Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate myocardial angiogenesis (time frame: 30-35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.