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

Lausanne University Hospital (CHUV)

Status: Terminated

Conditions: Myocardial Reperfusion; Myocardial Infarction, Acute; Chronic Ischemic Heart Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03809689

68Ga-NODAGA-RGD cardiac PET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

acute infarction

Other group

Description:

patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event

Treatment:

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 group

Description:

patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event

Treatment:

Other: 68Ga-NODAGA-RGD PET/CT

Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator

chronic ischemic occlusion

Other group

Description:

patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment

Treatment:

Other: 68Ga-NODAGA-RGD PET/CT

Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator