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

Primary Purpose

Myocardial Infarction, Acute, Myocardial Reperfusion, Chronic Ischemic Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
68Ga-NODAGA-RGD PET/CT
82-Rb PET/CT as part of standard care, not a comparator
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction, Acute focused on measuring Acute myocardial infarction, Myocardial reperfusion treatment, Chronic ischemic occlusion, 68Ga-NODAGA-RGD

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier Universitaire VaudoisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

acute infarction

acute infarction requiring reperfusion

chronic ischemic occlusion

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress
mL/min/g
82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress
mL/min/g
82Rb PET/CT : assessment of change of difference of myocardial blood flow at stress and at rest
mL/min/g
68Ga-NODAGA PET/CT : assessment of change of standard uptake value (SUV)
g/ml

Secondary Outcome Measures

Full Information

First Posted
December 2, 2018
Last Updated
July 13, 2023
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03809689
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Acute, Myocardial Reperfusion, Chronic Ischemic Heart Disease
Keywords
Acute myocardial infarction, Myocardial reperfusion treatment, Chronic ischemic occlusion, 68Ga-NODAGA-RGD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acute infarction
Arm Type
Other
Arm Description
patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
Arm Title
acute infarction requiring reperfusion
Arm Type
Other
Arm Description
patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
Arm Title
chronic ischemic occlusion
Arm Type
Other
Arm Description
patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment
Intervention Type
Other
Intervention Name(s)
68Ga-NODAGA-RGD PET/CT
Intervention Description
intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection
Intervention Type
Diagnostic Test
Intervention Name(s)
82-Rb PET/CT as part of standard care, not a comparator
Intervention Description
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
Primary Outcome Measure Information:
Title
82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress
Description
mL/min/g
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
Title
82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress
Description
mL/min/g
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
Title
82Rb PET/CT : assessment of change of difference of myocardial blood flow at stress and at rest
Description
mL/min/g
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
Title
68Ga-NODAGA PET/CT : assessment of change of standard uptake value (SUV)
Description
g/ml
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John O Prior, PhD, MD
Phone
+41 21 314 43 48
Email
john.prior@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John O Prior, PhD, MD
Organizational Affiliation
Lausanne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John O. Prior, MD, PhD
Phone
+41 (0)21-3144348
Email
john.prior@chuv.ch
First Name & Middle Initial & Last Name & Degree
John O. Prior, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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