NCT07107919招募中不适用
Multimodal Imaging Assessment of Chronic Kidney Disease Patients at Different Stages From a Cardio-Renal Interaction Perspective
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Myocardial fibrosis burden measured by 18F-FAPI PET/MR
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Myocardial fibrosis burden measured by 18F-FAPI PET/MR
时间窗: At baseline (within 1 week of enrollment)
Native T1 value, ECV, and LGE assessed by cardiac MRI to evaluate myocardial fibrosis
次要结局
未报告次要终点
研究者
研究点 (1)
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