CClinicalTrials.gg
TerminatedNCT03809689Updated Jun 20, 2024

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

An interventional study of 68Ga-NODAGA-RGD PET/CT and 82-Rb PET/CT as part of standard care, not a comparator in Myocardial Infarction, Acute, Myocardial Reperfusion and Chronic Ischemic Heart Disease, sponsored by University of Lausanne Hospitals. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Diagnostic

Why this study was terminated
lack of recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Acute myocardial infarction
  • Myocardial reperfusion treatment
  • Chronic ischemic occlusion
  • 68Ga-NODAGA-RGD
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 118 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • pregnancy, breastfeeding
  • claustrophobia
  • contra-indication to adenosine administration
  • lack of discernment to sign informed consent
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Other
    acute infarction

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

    Other: 68Ga-NODAGA-RGD PET/CT · Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator

  • Other
    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

    Other: 68Ga-NODAGA-RGD PET/CT · Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator

  • Other
    chronic ischemic occlusion

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

    Other: 68Ga-NODAGA-RGD PET/CT · Diagnostic Test: 82-Rb PET/CT as part of standard care, not a comparator

Interventions

  • Other68Ga-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 test82-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

06

What researchers measure

Primary outcomes

  1. 82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress

    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

  2. 82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress

    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

  3. 82Rb PET/CT : assessment of change of difference of myocardial blood flow at stress and at rest

    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

  4. 68Ga-NODAGA PET/CT : assessment of change of standard uptake value (SUV)

    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

07

Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, Vaud 1011, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03809689
Lead sponsor
University of Lausanne Hospitals
Responsible party
John O. Prior (PhD, MD, Head of Nuclear Medicine Department, University of Lausanne Hospitals) — Principal investigator
First posted
Jan 18, 2019
Start date
Nov 1, 2018
Primary completion
Sep 1, 2023
Completion
Oct 11, 2023
Last update
Jun 20, 2024

Study contacts

John O Prior, PhD, MD
principal investigator · University of Lausanne Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion