Arterial wall inflammation measured with 18F-FDG PET/CT in patients with statin intolerance before and after treatment with a PCSK-9 inhibitor

Academical medical centre, dep of internal medicine0 个研究点开始时间: 2017年2月28日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Increased CV-risk
•oClinical diagnosis of Familial Hypercholesterolemia, OR
•oPrevious CV-event, OR
•oImaging (CT, MRI, Angiography) compatible with atherosclerotic disease, OR
•o(very) high CV risk estimated by risk-engines (Framingham, Score, Procam)
•Aged 50 years or older
•Statin-associated Muscle symptoms (SAMS) for at least 3 different statins, precluding statin use
•LDL-C > 100 mg/dL
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Previous CV-event within 3 months prior to study screening visit
•Malignant disease in past five years or any medical condition that could interfere with the conduct of the study in the opinion of the investigator.
•Use of any dose of any statin
•Chronic or recent (<1 month) infections and/or clinical signs of acute infection
•and/or CRP>10 mg/L
•Auto-immune diseases
•Use of chronic immunosuppressant or antibiotics in the last 6 weeks
•Standard contra-indications to 18F-FDG PET/CT based on physicians experience and current practices
•Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
•Participation in a scientific study with radiation exposure in the year prior to inclusion.

发起方

Academical medical centre, dep of internal medicine