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

Not Applicable

Terminated

• Conditions: Myocardial Reperfusion; Myocardial Infarction, Acute; Chronic Ischemic Heart Disease
• Interventions: Other: 68Ga-NODAGA-RGD PET/CT; Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator

• Registration Number: NCT03809689
• Lead Sponsor: University of Lausanne Hospitals

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.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-12-02
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-18
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acute infarction	82-Rb PET/CT as part of standard care, not a comparator	patients 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	68Ga-NODAGA-RGD PET/CT	patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
acute infarction	68Ga-NODAGA-RGD PET/CT	patients 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	82-Rb PET/CT as part of standard care, not a comparator	patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
chronic ischemic occlusion	68Ga-NODAGA-RGD PET/CT	patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment
chronic ischemic occlusion	82-Rb PET/CT as part of standard care, not a comparator	patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment

Primary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland