- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03505346
68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Angiogenesis in Ischemic Heart Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ischemic heart disease is worldwide the single most frequent cause of death. The number of patients surviving acute myocardial injury is increasing due to improved acute treatment. However, after the initial repair, the tissue undergoes a remodeling phase to compensate for the damaged area. This re-modeling phase can change the structure end geometry of the heart resulting in lower ejection fraction, leading to cardiac dysfunction, which eventually leads to heart failure. Ischemic heart disease is most commently caused by arteriosclerosis of the coronary artery.
If chronic ischemic heart disease is left untreated, it will lead to symptoms to the patient. These symptons occur when the myocardiel oxygen demand exceeds the oxygen provided, due to coronary occlusion.
If the heart suffers from ischemia, the tissue reacts strongly to the hypoxia. The body will as a compensatory mechanism create new vessel to provide the tissue with oxygen. This is known as the biological process of angiogenesis. This complex process involves different angiogenic and pro-fibrotic transcription factors that initiate the restoration of capillaries by sprouting from the existing endothelial cells in response to hypoxia.
Integrin αvβ3 is a transmembrane cell surface receptor that is markedly upregulated in states of angiogenesis. It facilitates migration and proliferation and thereby allowing cells to respond to extracellular environment. Integrin αvβ3 is thus a key player in the angiogenic process. The integrin αvβ3 has a binding site for an RGD peptide (Arg-Gly-Asp motif) and this can be targeted by PET tracers.
RGD-based PET tracers have been shown to accumulate at the site of myocardial necrosis in both human and animal studies. The uptake before interventions may correlate to recovery of cardiac function and thus serve as a prognostic marker after intervention.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Simon Bentsen, MD
- Phone Number: +4535451793
- Email: simon.bentsen.01@regionh.dk
Study Contact Backup
- Name: Rasmus Ripa, MD
- Phone Number: +4535454011
- Email: rasmus.ripa@regionh.dk
Study Locations
-
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Region Hovedstaden
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Copenhagen, Region Hovedstaden, Denmark, 2100
- Department of Physiology, Nuclear Medicine and PET
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age over 50 years
- Patient with known chornic ischemic Heart disease admitted to Rigshospitalet to either PCI og CABG
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: percutanous coronary intervention(PCI)
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. two times.
14-21 days before intervention and 30-35 days after intervention
|
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
Other Names:
|
Experimental: Coronary artery bypass-graft(CABG)
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. two times.
14-21 days before intervention and 30-35 days after interventionintervention
|
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate myocardial angiogenesis
Time Frame: 30-35 days
|
Analysing change in uptake of 68Ga-NODAGA-E[c(RGDyK)]2 Positron Emission Tomography after intervention
|
30-35 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion
Time Frame: 30-35 days
|
Correlation between uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and change in myocardial perfusion after intervention using Rubidium 82 Positron Emission Tomography
|
30-35 days
|
Correlation between 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery
Time Frame: 30-35 days
|
Correlation between uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery using Magnetic Resonance after intervention
|
30-35 days
|
Correlatino between 68Ga-NODAGA-E[c(RGDyK)]2 and viability
Time Frame: 30-35 days
|
Correlation between uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability using Flour-Deoxy-Glucose Positron Emission Tomography after intervention
|
30-35 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Andreas Kjær, MD, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EUDRA-CT: 2017-002712-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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