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

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ClinicalTrials.gov Identifier: NCT03809689
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals

Tracking Information
First Submitted Date  ICMJE December 2, 2018
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • 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 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 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
Official Title  ICMJE Study of Acute and Chronic Myocardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Myocardial Infarction, Acute
  • Myocardial Reperfusion
  • Chronic Ischemic Heart Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • acute infarction
    patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
    Interventions:
    • Other: 68Ga-NODAGA-RGD PET/CT
    • Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator
  • acute infarction requiring reperfusion
    patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT at 1, 4 and 12 weeks after cardiac event
    Interventions:
    • Other: 68Ga-NODAGA-RGD PET/CT
    • Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator
  • chronic ischemic occlusion
    patients will have a 82-Rb and a 68Ga-NODAGA-RGD PET/CT before and 2 months after reperfusion treatment
    Interventions:
    • Other: 68Ga-NODAGA-RGD PET/CT
    • Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John O Prior, PhD, MD +41 21 314 43 48 john.prior@chuv.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809689
Other Study ID Numbers  ICMJE 68Ga-NODAGA-RGD cardiac PET
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John O. Prior, University of Lausanne Hospitals
Study Sponsor  ICMJE University of Lausanne Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John O Prior, PhD, MD Lausanne University Hospital
PRS Account University of Lausanne Hospitals
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP