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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorThe Affiliated Hospital of Qingdao University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients aged 18 to 80 years with clinically diagnosed chronic kidney disease (CKD), classified according to the KDIGO guidelines. Participants will be stratified into two groups based on renal function: Group I (CKD stages 1-3, eGFR ≥ 30 mL/min/1.73 m²) and Group II (CKD stages 4-5, eGFR \< 30 mL/min/1.73 m²). Subjects will be consecutively recruited from the Department of Nephrology and Cardiology of The Affiliated Hospital of Qingdao University. Both male and female patients will be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 18F PET/MR

    Other intervention

    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 3. First Pass Perfusion Imaging:Quantitatively assess the extent and severity of myocardial perfusion defects 4. Late Gadolinium Enhancement (LGE): Detect and quantify myocardial necrosis and fibrosis 5. T1 Mapping (Pre and Post Contrast): Quantify myocardial interstitial fibrosis 6. T2 Mapping (Pre Contrast):Quantify myocardial edema 7. Cardiac PET Imaging:Evaluate myocardial fibrosis characteristics using \^18F FAPI PET data

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group I (CKD stages 1-3)1 intervention
Group B: Group II (CKD stages 4-5)1 intervention

Trial outcomes

Primary outcomes

1

Myocardial fibrosis burden measured by 18F-FAPI PET/MR

Myocardial uptake of 18F-FAPI quantified using SUVmax and SUVmean values from PET imaging.

Time frame
At baseline (within 1 week of enrollment)
2

Myocardial fibrosis burden measured by 18F-FAPI PET/MR

Native T1 value, ECV, and LGE assessed by cardiac MRI to evaluate myocardial fibrosis

Time frame
At baseline (within 1 week of enrollment)

Secondary outcomes

Other outcomes

Sponsors and contacts

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