A prospective cohort study to investigate the use of alfa V beta 3 integrin scintigraphic imaging with 99mTC-NC100692 to predict scar formation and heart failure after myocardial infarction in patients. - ANG692

MUMC+0 个研究点开始时间: 2009年2月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•(1) The subject has had no previous MI, presents with acute MI and has undergone coronary angiography during which percutaneous coronary intervention (PCI) or no intervention may be performed.
•(2) The subject is =18 years of age at study entry.
•(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), 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.
•(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*
•(6) The subject has an LVEF of =40% and =55% and is NYHA class 1-2.
•* This inclusion criterion will be checked at 3 and 8 weeks post-MI.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•(1) The subject was previously entered into this study or has participated in any other IMP study within 30 days of study entry.
•(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.
•(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 with 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 investigator(s) makes the subject unsuitable for participation of the study.
•(6) The subject is scheduled to have a revascularisation procedure (e.g., PCI or CABG) or cardiac transplant in the 30 days after study entry.
•(7) The subject participated in a research study using ionising radiation within 12 months of study entry.

发起方

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