NL-OMON35493撤回2 期
A prospective cohort study to investigate the use of avβ3-integrin scintigraphic imaging with 99mTc-NC100692 injection as a surrogate endpoint for therapeutic interventions in patients with myocardial infarction. - avβ3-integrin imaging as a surrogate endpoint after myocardial infarction
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 82 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •(1) The subject has had no previous MI (a previous MI/scar could potentially result in tracer uptake and therefore interfere with the imaging outcome), presents with acute MI and has undergone coronary angiography during which percutaneous coronary intervention (PCI) or no intervention may be performed. The documentation of coronary anatomy and disease will be linked to the imaging outcome.;(2) The subject is >=35 years of age at study entry. Maximum age is 80 years, provided patients are in good medical condition.;(3) The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained, including permission to access coronary angiography records (see inclusion criterion No. 1), before any study procedure is carried out. ;(4) The subject is male, or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), sterilized by tubaligation, postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a urine pregnancy test performed before administration of 99mTc-NC100692 Injection is negative, to prevent potential harm to the potentially present unborn foetus.;(5) The subject has been clinically stable (e.g., not experiencing continuing chest pain or haemodynamic instability) for at least 7 days before each imaging session with 99mTcNC100692 Injection*. (An unstable patient would be put to risk unnecessarily if subjected to an imaging study and will therefore be excluded.);(6) The subject has an LVEF of >=40% and <=55% and is NYHA class 1-2: Patients with EF below 40% have to receive spironolactone/eplerenone according to the guidelines. In patients with EF above 55%, the infarct will be too small for significant tracer uptake.;* This inclusion criterion will be checked at 3 and 8 weeks post-MI.
排除标准
- •(1) The subject was previously entered into this study or has participated in any other IMP study within 30 days of study entry, since this could interfere with the medications tested.;(2) The subject is scheduled to receive another IMP from time of entry into this study until completion of the follow-up period after the second injection proposed for this study, since this could interfere with the medications and endpoints tested.;(3) The subject has known allergies to any product used in this study or its constituents (e.g., para-amino benzoic acid). ;(4) The subject undergoes monitoring of occupational radiation exposure. ;(5) The subject presents with any other clinically active, serious, life-threatening disease and has a life expectancy of less than 12 months, where participation in the study might compromise the management of the subject, or for any other reason that in the judgement of the investigators makes the subject unsuitable for participation in the study. ;(6) The subject is scheduled to have a revascularisation procedure (e.g., PCI or CABG) in the 30 days after study entry or cardiac transplantion. ;(7) The subject participated in a research study using ionising radiation within 12 months of study entry, to prevent the patients receiving more than the maximal recommended yearly exposure to ionizing radiation.
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