Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Occurrence of a severe cardiological event
研究概览
简要总结
Cardiac damage is the second leading cause of death in patients with sarcoidosis, after lung damage. Today's challenge is to diagnose the disease as effectively as possible, and to develop tools for better risk stratification, especially for sudden death, in order to better target therapies and implantable devices, such as corticoids and immunosuppressant.
The hypothesis is that combined PET (Positron Emission Tomography)/MRI (Magnetic Resonance Imaging) could be a relevant prognostic marker of progression, and would significantly improve diagnostic performance in patients with suspected cardiac sarcoidosis (CS). This study will also make it possible to distinguish sequellar fibrosis lesions from granulomatous lesions and assess the therapeutic response. Incorporating PET/MRI into the diagnostic strategy for patients with suspected CS could therefore improve their management.
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
- 否
入选标准
- •Age ≥ 18 years
- •Sarcoidosis defined according to ATS/ERS/WASOG criteria
- •Suspicion of cardiac involvement in sarcoidosis:
- •Clinical manifestations (syncope, lipothymia, persistent palpitations, signs of heart failure) and/or
- •Cardiac rhythm or conduction disorder (Mobitz type 2 atrioventricular block (AVB), AVB 3, right or left bundle branch block, Q wave in at least 2 leads, ventricular arrhythmia (ventricular mono/polymorphic complexes> 1000 per 24 h, ventricular tachycardia, ventricular fibrillation), unexplained sustained VT or epsilon wave) and/or
- •Compatible cardiac ultrasound abnormality: left ventricular dilatation, septal thickening or wall thinning (especially basal), segmental kinetic disorder and wall aneurysm without coronary anomaly, altered left ventricular ejection fraction, altered diastolic function, altered right ventricular systolic function.
- •Informed patient consent
- •Membership of a social security scheme
排除标准
- •Psychiatric illness not controlled by treatment
- •Claustrophobia
- •Known pregnancy or breast-feeding patient
- •Unbalanced diabetes (influence on carbohydrate metabolism for PET)
- •Previous infarction or known coronary disease
- •Known allergy to gadolinium and fluoro-desoxyglucose and their excipients
- •Renal insufficiency (Clairance < 30 mL/min/1.73m2)
- •Implanted pacemaker not compatible with a 3 Teslas magnetic field
- •Patients with ocular metallic foreign bodies, pacemakers, neurostimulators, cochlear implants, metallic heart valves, vascular clips formerly implanted on cranial aneurysms and, in general, any non-removably implanted electronic medical equipment
- •Inability or refusal to follow a low-carbohydrate diet for 24 hours, followed by a 6-hour fast required prior to the examination
- •Patient unable to hold a 10-second apnea.
- •Patient deprived of liberty by judicial or administrative decision
- •Patient under legal protection (guardianship, curatorship)
- •Participation in other interventional research involving the human person or being in the exclusion period following previous research involving the human person
- •Patients under AME
- •Exclusion criteria (post signature of consent) for women of reproductive age :
- •Positive pregnancy test result after inclusion
研究组 & 干预措施
Prospective cohort of patients
Patients with suspected cardiac sarcoidosis
干预措施: PET/MRI (Diagnostic Test)
结局指标
主要结局
Occurrence of a severe cardiological event
时间窗: Up to 24 months
Occurrence during follow-up of at least one of the severe cardiological events listed below attributed to sarcoidosis, assessed at 24 months: * Death from cardiac causes. * Placement of an automatic implantable defibrillator or pacemaker. * Conduction disorder (Mobitz type 2 atrioventricular block (AVB), AVB 3, ventricular arrhythmia (ventricular mono/polymorphic complexes \> 1000 per 24 h, ventricular tachycardia (VT), ventricular fibrillation), unexplained sustained VT). * Degradation of cardiac function of more than 10% of LVEF assessed by transthoracic (TTE) or cardiac MRI. * Acute heart failure with no other known cause
次要结局
- Frequency of severe cardiological events according to each modality of PET/MRI results in terms of Delayde MRI enhancement and hypermetabolic fixation on PET.(Up to month 24.)
- Frequency of severe cardiological events between patients with and without Delayde MRI enhancement(Up to 24 months.)
- Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement(Up to month 24.)
- Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment.(Up to month 3 and 12.)