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临床试验/NCT03275584
NCT03275584招募中4 期

Sûreté de la Perfusion Myocardique Par la Tomographie d'émission Par Positron Avec l'Ammoniaque marqué au N-13 du Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2018年1月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
20,000
试验地点
1
主要终点
Adverse reaction to the N-13 ammonia injection

研究概览

简要总结

Positron emission tomography (PET) myocardial perfusion imaging (MPI) is an examination that helps to assess the function and perfusion of the heart. Completion of this examination requires the injection of a small dose of a radiotracer (a radioactive substance).

PET MPI is a state-of-the-art non-invasive cardiac imaging tool. The main goal of the PET MPI examination is to assess if one or more of the arteries feeding blood to your heart are blocked. This examination replaces an older technology (single photon emission computed tomography, or SPECT), and allows the obtention of more accurate information, and new information that the older SPECT technology did not assess. The radiation dose received as part of the procedure is also smaller with PET versus SPECT.

One of the substances which can be used for PET MPI is called N-13 ammoniac (NH3). For this clinical study, NH3 which will be produced at the Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), per the standards and methods prescribed by Health Canada. NH3 is not currently approved for clinical use by Health Canada. It is thus considered and experimental substance in the context of this study.

Participants will undergo PET MPI with the CRCHUM NH3. The PET MPI procedure itself is not an experimental procedure and is not part of the research protocol. Only the use of NH3 produced at the CRCHUM is experimental.

The main objective of this research study is to validate the production process and assess the safety of the NH3 produced at the CRCHUM cyclotron. Secondary objectives include the assessment of prescription practices amongst physicians who refer patients for PET MPI, and how they will change over time.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient being referred for clinically indicated positron emission tomography myocardial perfusion imaging at the Centre hospitalier de l'Université de Montréal

排除标准

  • Pregnant women
  • Claustrophobic patient unable to undergo the examination
  • Breastfeeding women unwilling to temporarily stop breastfeeding
  • Patient with contra-indication to: dipyridamole, aminophylline, dobutamine or exercise stress test (depending on the method of cardiovascular stress test chosen)

研究组 & 干预措施

Main arm

Experimental

N-13 ammonia intravenous injection; 2 injections, 3-7 MBq/kg per injection

干预措施: N-13 ammonia intravenous injection (Drug)

结局指标

主要结局

Adverse reaction to the N-13 ammonia injection

时间窗: 1 hour

The absence or presence of adverse reactions related to the N-13 ammonia injection, as a simple yes or no. The following tools will be used to establish the presence/absence of adverse reaction: * Questionnaire during and after the procedure * Vital signs monitoring before, during and after the procedure * Patient's self-reported side-effects from the procedure

次要结局

  • Incidence of specific adverse reactions to N-13 ammonia injection(1 hour)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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Safety of PET MPI Using the CRCHUM N-13 Ammonia | 临床试验