Myocardial Infarction, AcuteNCT03809689
Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
A study testing 68Ga-NODAGA-RGD PET/CT in people with Myocardial Infarction, Acute and Myocardial Reperfusion, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The study is about exploring physiological angiogenesis linked to tissue repair in patients with acute heart infarction or chronic heart ischemia by means of 68Ga-NODAGA-RGD PET/CT imaging. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction, Acute, Myocardial Reperfusion, Chronic Ischemic Heart Disease
- What is being tested?
- 68Ga-NODAGA-RGD PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2018to 11 Oct 2023
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with acute infarction or patients with acute infarction requiring reperfusion treatment or patients with chronic ischemic occlusion
- Karnofsky ≥ 80%
- signed informed consent
Who cannot join
- pregnancy, breastfeeding
- claustrophobia
- contra-indication to adenosine administration
- lack of discernment to sign informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Study of Acute and Chronic Myocardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
The study is about exploring physiological angiogenesis linked to tissue repair in patients with acute heart infarction or chronic heart ischemia by means of 68Ga-NODAGA-RGD PET/CT imaging.
Read the detailed description
Several animal studies have demonstrated the expression of αvβ3 integrins on the surface of the endothelium present in neovessels in formation, especially during neoangiogenesis after myocardial ischemic injury.
68Ga-NODAGA-RGD is a positron-emission-tomography (PET) ligand targeted towards αvβ3 integrins. αvβ3 integrins could potentially act as a biomarker for the follow-up of heart infarction.
In the present study, 68Ga-NODAGA-RGD PET/CT imaging is a tool to understand and evaluate tissue repair after heart lesion and its evolution allowing a better management of patients with occluded artery.
Three groups of patients are included : patients with acute infarction, patients with acute infarction requiring reperfusion treatment and patients with chronic ischemic occlusion.
Each patient would benefit from a 82Rb (82rubidium) PET/CT as part of standard management and from a 68Ga-NODAGA-RGD PET/CT as part of the present study.
Patients from groups 1 and 2 will have 3 sets of both exams : one after the ischemic event, one at one month and another at 3 months post event.
Patients form group 3 will have a set of both exams before reperfusion treatment and one at 2 months after reperfusion.
- Being tested
- 68Ga-NODAGA-RGD PET/CT, 82-Rb PET/CT as part of standard care, not a comparator
- Keywords
- Acute myocardial infarction, Myocardial reperfusion treatment, Chronic ischemic occlusion, 68Ga-NODAGA-RGD
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-RGD PET/CTOther
intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection
82-Rb PET/CT as part of standard care, not a comparatorDiagnostic test
2 intravenous injections of standard dose of 82-Rb : the first followed by an at-rest acquisition, the second followed by a pharmacological myocardial stress acquisition
| Study group | Role | What they receive |
|---|---|---|
| acute infarction | Other | patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event Receives: Other: 68Ga-NODAGA-RGD PET/CT; Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator |
| acute infarction requiring reperfusion | Other | patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event Receives: Other: 68Ga-NODAGA-RGD PET/CT; Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator |
| chronic ischemic occlusion | Other | patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment Receives: Other: 68Ga-NODAGA-RGD PET/CT; Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress
mL/min/g
Measured: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress
mL/min/g
Measured: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
82Rb PET/CT : assessment of change of difference of myocardial blood flow at stress and at rest
mL/min/g
Measured: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
68Ga-NODAGA PET/CT : assessment of change of standard uptake value (SUV)
g/ml
Measured: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Nov 2018
- Primary completion1 Sep 2023
- Study completion11 Oct 2023
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John O. Prior, University of Lausanne Hospitals
- Investigators
- John O Prior, PhD, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809689
- Sponsor's protocol ID
- 68Ga-NODAGA-RGD cardiac PET
- Status last verified
- Jun 2024
- First submitted
- 2 Dec 2018
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dietz M, Kamani CH, Bousige C, Dunet V, Delage J, Rubimbura V, Nicod Lalonde M, Treglia G, Schaefer N, Nammas W, Saraste A, Knuuti J, Mewton N, Prior JO. Natural History of Myocardial alphavbeta3 Integrin Expression After Acute Myocardial Infarction: Correlation with Changes in Myocardial Blood Flow. J Nucl Med. 2024 Jul 1;65(7):1107-1112. doi: 10.2967/jnumed.124.267514.
PubMed 38724280
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Acute and Chronic Myocardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
- ClinicalTrials.gov ID
- NCT03809689
- Acronym / sponsor ID
- 68Ga-NODAGA-RGD cardiac PET
- Keywords
- Acute myocardial infarction, Myocardial reperfusion treatment, Chronic ischemic occlusion, 68Ga-NODAGA-RGD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 18 Jan 2019 (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 study is about exploring physiological angiogenesis linked to tissue repair in patients with acute heart infarction or chronic heart ischemia by means of 68Ga-NODAGA-RGD PET/CT imaging.
Detailed description
Several animal studies have demonstrated the expression of αvβ3 integrins on the surface of the endothelium present in neovessels in formation, especially during neoangiogenesis after myocardial ischemic injury.
68Ga-NODAGA-RGD is a positron-emission-tomography (PET) ligand targeted towards αvβ3 integrins. αvβ3 integrins could potentially act as a biomarker for the follow-up of heart infarction.
In the present study, 68Ga-NODAGA-RGD PET/CT imaging is a tool to understand and evaluate tissue repair after heart lesion and its evolution allowing a better management of patients with occluded artery.
Three groups of patients are included : patients with acute infarction, patients with acute infarction requiring reperfusion treatment and patients with chronic ischemic occlusion.
Each patient would benefit from a 82Rb (82rubidium) PET/CT as part of standard management and from a 68Ga-NODAGA-RGD PET/CT as part of the present study.
Patients from groups 1 and 2 will have 3 sets of both exams : one after the ischemic event, one at one month and another at 3 months post event.
Patients form group 3 will have a set of both exams before reperfusion treatment and one at 2 months after reperfusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acute infarction | Other | Other: 68Ga-NODAGA-RGD PET/CT, Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparatorpatients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event |
| acute infarction requiring reperfusion | Other | Other: 68Ga-NODAGA-RGD PET/CT, Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparatorpatients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event |
| chronic ischemic occlusion | Other | Other: 68Ga-NODAGA-RGD PET/CT, Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparatorpatients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with acute infarction or patients with acute infarction requiring reperfusion treatment or patients with chronic ischemic occlusion
- Karnofsky ≥ 80%
- signed informed consent
Key exclusion criteria (4 listed)
- pregnancy, breastfeeding
- claustrophobia
- contra-indication to adenosine administration
- lack of discernment to sign informed consent
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-RGD PET/CTintravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection | Other | acute infarction, acute infarction requiring reperfusion, chronic ischemic occlusion |
| 82-Rb PET/CT as part of standard care, not a comparator2 intravenous injections of standard dose of 82-Rb : the first followed by an at-rest acquisition, the second followed by a pharmacological myocardial stress acquisition | Diagnostic test | acute infarction, acute infarction requiring reperfusion, chronic ischemic occlusion |
Primary outcome
82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress
Time frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
mL/min/g
82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress
Time frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
mL/min/g
82Rb PET/CT : assessment of change of difference of myocardial blood flow at stress and at rest
Time frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
mL/min/g
68Ga-NODAGA PET/CT : assessment of change of standard uptake value (SUV)
Time frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
g/ml
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Derived from this study: PubMed 38724280Dietz M, Kamani CH, Bousige C, Dunet V, Delage J, Rubimbura V, Nicod Lalonde M, Treglia G, Schaefer N, Nammas W, Saraste A, Knuuti J, Mewton N, Prior JO. Natural History of Myocardial alphavbeta3 Integrin Expression After Acute Myocardial Infarction: Correlation with Changes in Myocardial Blood Flow. J Nucl Med. 2024 Jul 1;65(7):1107-1112. doi: 10.2967/jnumed.124.267514.
- 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.
John O Prior, PhD, MD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-NODAGA-RGD PET/CT in people with Myocardial Infarction, Acute and Myocardial Reperfusion, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Jun 2024. 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 Switzerland. 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.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress (time frame: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809689, which also lists 1 linked publication.
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 20 Jun 2024.