Clinical trial NCT03809689: Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
Official title: Study of Acute and Chronic Myocardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocardial Infarction, Acute
Myocardial Reperfusion
Chronic Ischemic Heart Disease
Keywords: Acute myocardial infarction
Myocardial reperfusion treatment
Chronic ischemic occlusion
68Ga-NODAGA-RGD
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress
timeFrame: 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
measure: 82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress
timeFrame: 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
measure: 82Rb PET/CT : assessment of change of difference of myocardial blood flow at stress and at rest
timeFrame: 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
measure: 68Ga-NODAGA PET/CT : assessment of change of standard uptake value (SUV)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: John O Prior, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: