NCT03809689

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

4.8 years

First QC Date

December 2, 2018

Last Update Submit

June 17, 2024

Conditions

Myocardial Infarction, AcuteMyocardial ReperfusionChronic Ischemic Heart Disease

Keywords

Acute myocardial infarctionMyocardial reperfusion treatmentChronic ischemic occlusion68Ga-NODAGA-RGD

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

acute infarction

OTHER

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

acute infarction requiring reperfusion

OTHER

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

chronic ischemic occlusion

OTHER

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

Interventions

68Ga-NODAGA-RGD PET/CTOTHER

intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection

acute infarctionacute infarction requiring reperfusionchronic ischemic occlusion
82-Rb PET/CT as part of standard care, not a comparatorDIAGNOSTIC_TEST

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

acute infarctionacute infarction requiring reperfusionchronic ischemic occlusion

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with acute infarction or patients with acute infarction requiring reperfusion treatment or patients with chronic ischemic occlusion
  • Karnofsky ≥ 80%
  • signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • John O Prior, PhD, MD

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD, Head of Nuclear Medicine Department

Study Record Dates

First Submitted

December 2, 2018

First Posted

January 18, 2019

Study Start

November 1, 2018

Primary Completion

September 1, 2023

Study Completion

October 11, 2023

Last Updated

June 20, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)