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68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Myocardial Angiogenesis

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ClinicalTrials.gov Identifier: NCT03445884
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Simon Bentsen, Rigshospitalet, Denmark

Brief Summary:
The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with myocardial infarction and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: 68Ga-NODAGA-E[c(RGDyK)]2 Phase 2

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. Understanding and ideally modifying the reparative mechanisms following myocardial infarction is increasingly important and may lead to improved outcome.

If the heart suffers from ischemia following an acute coronary event, 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.

Time seem essential to protect and save the myocardium. An early onset of cytokines and growth factors is associated with a decline in cardiomyocytes apoptosis, smaller infarct areas, and decreased ventricular dilation. Therefore, an early induction of angiogenesis seems important for a good prognosis of the patient.

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 seems to peak a few weeks after the infarction and may correlate to recovery of cardiac function and thus serve as a prognostic marker.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 68Ga-NODAGA-E[c(RGDγK)]2: a Novel Positron Emission Tomography (PET) Tracer for in Vivo Molecular Imaging of Myocardial Angiogenesis Following Myocardial Infarction
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Acute myocardial infarctions group
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. three times. 1-3 days after intervention, 7-10 days after intervention and 30-35 days after intervention.
Drug: 68Ga-NODAGA-E[c(RGDyK)]2
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
Other Name: RGD-PET

Active Comparator: Control group
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. one time.
Drug: 68Ga-NODAGA-E[c(RGDyK)]2
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
Other Name: RGD-PET




Primary Outcome Measures :
  1. To evaluate myocardial angiogenesis [ Time Frame: 30-35 days ]
    Analysing uptake of 68Ga-NODAGA-E[c(RGDyK)]2 Positron Emission Tomography in myocardial infarction after PCI


Secondary Outcome Measures :
  1. Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion [ Time Frame: 30-35 days ]
    Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and change in myocardial perfusion after PCI using Rubidium 82 Positron Emission Tomography after Percutaneous coronary intervention(PCI)

  2. Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery [ Time Frame: 30-35 days ]
    Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery using Magnetic Resonance after PCI

  3. Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability [ Time Frame: 30-35 days ]
    Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability using Flour-Deoxy-Glucose Positron Emission Tomography after PCI



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age over 50 years

Acute myocardial infarction Group:

  • Verified first-time acute myocardial infarction treated with PCI

Control Group:

  • Previous healthy
  • No known cardiac disease

Exclusion Criteria:

  • No prior history of acute coronary infarction
  • 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)
  • 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¨
  • Tupe I or II diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445884


Contacts
Contact: Simon Bentsen, MD +4535451793 simon.bentsen.01@regionh.dk
Contact: Rasmus Ripa, MD +4535454011 rasmus.ripa@regionh.dk

Locations
Denmark
Department of Physiology, Nuclear Medicine and PET Recruiting
Copenhagen, Region Hovedstaden, Denmark, 2100
Contact: Simon Bentsen, MD    +4535451793    simon.bentsen.01@regionh.dk   
Contact: Rasmus Ripa, MD    +4535454011    rasmus.ripa@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Andreas Kjær, MD Rigshospitalet, Denmark

Responsible Party: Simon Bentsen, Medical Doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03445884     History of Changes
Other Study ID Numbers: EUDRACR-number: 2017-002709-36
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Simon Bentsen, Rigshospitalet, Denmark:
positron emission tomography
nuclear medicine
prognosis

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases