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Clinical Trials/NCT03809689
NCT03809689
Terminated
N/A

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

University of Lausanne Hospitals1 site in 1 country24 target enrollmentNovember 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Myocardial Infarction, Acute
Sponsor
University of Lausanne Hospitals
Enrollment
24
Locations
1
Primary Endpoint
82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress
Status
Terminated
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
October 11, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Lausanne Hospitals
Responsible Party
Principal Investigator
Principal Investigator

John O. Prior

PhD, MD, Head of Nuclear Medicine Department

University of Lausanne Hospitals

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

Outcomes

Primary Outcomes

82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Study Sites (1)

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