68Ga-DOTATATE PET-CTA imaging for the early detection of progressing coronary atherosclerosis - IPROGRESS

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 250 人开始时间: 2018年4月4日最近更新: 2019年1月7日

适应症

试验速览

暂无简介。

•-Patients with a coronary artery calcium score (CACS) measured with a low-dose CT between 100 and 1000 and absence of significant ischemia (= 12 % of the myocardium) on myocardial perfusion scintigraphy.
•-Age = 18 years
•-Affiliation to a social security regime
•-Signed informed consent.
•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 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 250

•-Previous acute coronary syndrome or coronary revascularisation
•- LVEF < 40 %
•- Previous severe adverse reaction to iodinated contrast agent
•-Irregular heart rhythm (chronic atrial fibrillation, numerous extrasystoles)
•- Severe asthma
•- Chronic kidney disease (eGFR < 45 ml/min/1.73 m2)
•-Waldenstrom disease
•-Multiple myeloma
•- Autoimmune / inflammatory disease requiring immunosuppressive treatment.
•- Active cancer.
•-Confirmed or suspected pregnancy
•-Impossibility to stay immobile and maintain the supine position during 30 minutes.
•- Patient deprived of liberty or under legal protection measure
•- Participation to an interventional trial involving the use of radiation during the two years of the study.
•- Participation to an interventional trial with the use of new drugs between the inclusion and one month after injecting 68Ga-DOTATATE (expected time period when SAE might occur in relation to the injection of DOTATATE).

发起方