Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET

Study Overview
=================
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.

Official Title
-----------------
Study of Acute and Chronic Myocardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET

Conditions
-----------------
Myocardial Infarction, Acute, Myocardial Reperfusion, Chronic Ischemic Heart Disease

Intervention / Treatment
-----------------
* Other: 68Ga-NODAGA-RGD PET/CT
* Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: acute infarction<br>patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event | Other: 68Ga-NODAGA-RGD PET/CT<br>* intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection<br>Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator<br>* 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<br>|
| Other: acute infarction requiring reperfusion<br>patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event | Other: 68Ga-NODAGA-RGD PET/CT<br>* intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection<br>Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator<br>* 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<br>|
| Other: chronic ischemic occlusion<br>patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment | Other: 68Ga-NODAGA-RGD PET/CT<br>* intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection<br>Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress | mL/min/g | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myocardial infarction, Myocardial reperfusion treatment, Chronic ischemic occlusion, 68Ga-NODAGA-RGD