68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Angiogenesis in Ischemic Heart Disease
1 other identifier
interventional
42
1 country
1
Brief Summary
The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with chronich ischemic heart disease and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis after intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 23, 2018
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 21, 2023
November 1, 2023
1.9 years
March 5, 2018
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate myocardial angiogenesis
Analysing change in uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 Positron Emission Tomography after intervention
30-35 days
Secondary Outcomes (3)
Correlation between 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion
30-35 days
Correlation between 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery
30-35 days
Correlatino between 68Ga-NODAGA-E[c(RGDyK)]2 and viability
30-35 days
Study Arms (2)
percutanous coronary intervention(PCI)
EXPERIMENTAL200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 administered IV. two times. 14-21 days before intervention and 30-35 days after intervention
Coronary artery bypass-graft(CABG)
EXPERIMENTAL200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 administered IV. two times. 14-21 days before intervention and 30-35 days after interventionintervention
Interventions
200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 administered IV.
Eligibility Criteria
You may qualify if:
- Age over 50 years
- Patient with known chornic ischemic Heart disease admitted to Rigshospitalet to either PCI og CABG
You may not qualify if:
- No prior history of Heart surgery
- Not treated with anti-angiogenic medicine
- Subject with pacemaker, cochlear implant or insulin pump
- Pregnancy
- Lactation
- Severe claustrophobia
- Severe obesity (weight above 140kg)
- Conversion from PCI to CABG
- If a subject is in the fertile age, a pregnancy test will be use prior to injection to the PET\_tracer
- If a subject is having a severe allergic reaction to the PET-tracer, the person will be excluded for the rest of the trial
- If the PET-tracer is administered subcutaneous, the person will be excluded for the rest of the trial¨
- Type I or II diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physiology, Nuclear Medicine and PET
Copenhagen, Capital Region, 2100, Denmark
Study Officials
- STUDY DIRECTOR
Andreas Kjær, MD
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
March 5, 2018
First Posted
April 23, 2018
Study Start
January 1, 2024
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
November 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share