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Идёт набор NCT07107919

Multimodal Imaging Assessment of Chronic Kidney Disease Patients at Different Stages From a Cardio-Renal Interaction Perspective

— Наблюдательное Chronic Kidney Disease Cardiac Magnetic Resonance 18F-FAPI

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: 18F PET/MR.
Кому может быть актуально
Состояния в реестре: Chronic Kidney Disease, Cardiac Magnetic Resonance, 18F-FAPI. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
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Обзор

This study is a prospective cohort investigation in which consecutive eligible patients undergo 18F-FAPI PET/MR imaging. Chronic kidney disease (CKD) participants are stratified into two groups:Group I ：CKD stages 1-3（eGFR ≥ 30 mL/min/1.73 m²）,Group II :CKD stages 4-5(eGFR \< 30 mL/min/1.73 m²). Using 18F-FAPI PET/MR, we will evaluate global cardiac functional impairment and myocardial fibrosis characteristics, and analyze their associations with the degree of renal dysfunction.

Вмешательства

  • Другое 18F PET/MR
    Tracer: \^18F FAPI 04 is used in this study. A single intravenous bolus dose of 3.70-4.44 MBq/kg is administered. • Simultaneous PET/MR Acquisition: During PET imaging, cardiac MR (CMR) is performed in the supine position. All images are acquired with ECG gating and respiratory gating, during end expiratory breath holds. 1. Cardiac Morphology and Function (Localization \& Cine):Assess cardiac structure and global/regional function 2. T2 Weighted Fat Suppressed Imaging:Evaluate myocardial edema

Первичные конечные точки

  • Myocardial fibrosis burden measured by 18F-FAPI PET/MR [Срок оценки: At baseline (within 1 week of enrollment)]
  • Myocardial fibrosis burden measured by 18F-FAPI PET/MR [Срок оценки: At baseline (within 1 week of enrollment)]

Критерии участия

Критерии включения

  • Age between 18 and 80 years, regardless of sex.
  • Clinically diagnosed with chronic kidney disease (CKD), based on KDIGO guidelines.
  • Complete clinical data available.
  • Written informed consent for participation and for undergoing 18F-FAPI PET/MR imaging is obtained from the patient or their legal guardian.
  • Female participants must agree to use effective contraception during the study and for at least 6 months after its completion (e.g., sterilization, intrauterine hormonal devices, condoms, hormonal contraceptives, abstinence, or vasectomized partner). Male participants must also agree to use contraception during the study and for 6 months after its completion.

Критерии исключения

  • Women who are planning to conceive, currently pregnant, or breastfeeding.
  • Contraindications to PET/MR imaging, including but not limited to metal implants, claustrophobia, or inability to tolerate cardiac MRI due to respiratory difficulties.
  • History of allergy or hypersensitivity to gadolinium-based contrast agents.
  • Presence of malignant tumors or other serious progressive diseases.
  • Patients with severe cardiac conditions, such as advanced heart failure, severe valvular disease, or cardiomyopathies.
  • Hemodynamic instability.
  • Presence of severe systemic or localized infections, or other serious comorbid conditions.
  • Incomplete clinical data.
  • Any other reason deemed by the investigators to make the subject unsuitable for participation, including inability or unwillingness to comply with study procedures and requirements.
  • Determined by the investigators to be inappropriate for inclusion in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • The Affiliated Hospital of Qingdao University — Qingdao

Идентификаторы

NCT: NCT07107919 · QYFYEC2025-103

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗