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

Myocardial Infarction, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03809689
• Other study ID #: 68Ga-NODAGA-RGD cardiac PET
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 28, 2023

Study information

• Verified date: July 2023
• Source: University of Lausanne Hospitals
• Contact: John O Prior, PhD, MD
• Phone: +41 21 314 43 48
• Email: john.prior[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Ischemic Heart Disease
• Coronary Artery Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute
• Myocardial Ischemia
• Myocardial Reperfusion

Intervention

Other:
• 68Ga-NODAGA-RGD PET/CT
intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection

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

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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