Идёт набор NCT05954507

Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis

Без фазы С лечением Cardiac Sarcoidosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: PET/MRI.
Кому может быть актуально: Состояния в реестре: Cardiac Sarcoidosis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective Comparative Multicenter Study Evaluating the Prognostic Interest of PET/MRI in Cardiac Sarcoidosis

Обзор

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.

Вмешательства

Диагностический тест PET/MRI
PET/MRI is a new-generation hybrid camera capable of simultaneously performing FDG positron emission tomography and gadolinium-injected MRI. PET/MRI could be a relevant prognostic marker of progression, and could significantly improve diagnostic performance in patients with suspected cardiac sarcoidosis.

Первичные конечные точки

Occurrence of a severe cardiological event [Срок оценки: Up to 24 months]

Вторичные конечные точки (4)

Frequency of severe cardiological events between patients with and without Delayde MRI enhancement [Срок оценки: Up to 24 months.]
Frequency of severe cardiological events according to each modality of PET/MRI results in terms of Delayde MRI enhancement and hypermetabolic fixation on PET. [Срок оценки: Up to month 24.]
Percentage of patients initially well classified (diagnostic accuracy) in terms of probability of cardiac involvement [Срок оценки: Up to month 24.]
Comparison of FDG PET metabolic activity and late gadolinium enhancement of pathological areas before and after treatment. [Срок оценки: Up to month 3 and 12.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет