Chronic Ischemic Heart Disease, Myocardial Infarction, Acute, Myocardial Reperfusion
Conditions
Keywords
Acute myocardial infarction, Myocardial reperfusion treatment, Chronic ischemic occlusion, 68Ga-NODAGA-RGD
Brief 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.
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.
Interventions
intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection
DIAGNOSTIC_TEST82-Rb PET/CT as part of standard care, not a comparator
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
Sponsors
University of Lausanne Hospitals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients with acute infarction or patients with acute infarction requiring reperfusion treatment or patients with chronic ischemic occlusion * Karnofsky ≥ 80% * signed informed consent
Exclusion criteria
* pregnancy, breastfeeding * claustrophobia * contra-indication to adenosine administration * lack of discernment to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress | 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 | 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 | 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) | 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 |
Countries
Switzerland
Outcome results
None listed