68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Myocardial Angiogenesis
68Ga-NODAGA-E[c(RGDγK)]2: a Novel Positron Emission Tomography (PET) Tracer for in Vivo Molecular Imaging of Myocardial Angiogenesis Following Myocardial Infarction
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Region Hovedstaden
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Copenhagen、Region Hovedstaden、デンマーク、2100
- Department of Physiology, Nuclear Medicine and PET
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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.
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200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 を IV 投与。
他の名前:
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アクティブコンパレータ:Control group
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. one time.
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200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 を IV 投与。
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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To evaluate myocardial angiogenesis
時間枠:30-35 days
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Analysing uptake of 68Ga-NODAGA-E[c(RGDyK)]2 Positron Emission Tomography in myocardial infarction after PCI
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30-35 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion
時間枠:30-35 days
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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)
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30-35 days
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Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery
時間枠:30-35 days
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Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery using Magnetic Resonance after PCI
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30-35 days
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Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability
時間枠:30-35 days
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Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability using Flour-Deoxy-Glucose Positron Emission Tomography after PCI
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30-35 days
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協力者と研究者
スポンサー
捜査官
- スタディディレクター:Andreas Kjær, MD、Rigshospitalet, Denmark
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
68Ga-NODAGA-E[c(RGDyK)]2の臨床試験
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