Atherosclerotic cardiovascular disease, arteritis, arterial thrombotic disorders, venous thromboembolic diseases, intracardiac thrombosis, and lymphatic disorders.
Conditions
Interventions
Patients with inflammatory plaques group:none
Patients with non-inflammatory plaques group:none
Sponsors
Shanghai Tenth People‘s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Suspected or confirmed panvascular disease involving =1 vascular bed(s) throughout the body; 3. Participants voluntarily enrolled in this study, provided written informed consent, and demonstrated good compliance. 4. Subjects should have no plans for pregnancy during the study period (from 2 weeks prior to initiation through 6 months after the last administration) and must practice effective contraception throughout this timeframe.
Exclusion criteria
Exclusion criteria: 1. Subjects with hypersensitivity to: The investigational drug or its metabolites Any excipients (primarily iron and dextran); 2. Serum ferritin >=1000 µg/L and transferrin saturation >=50%; 3. Pregnancy; 4. Subjects with non-MRI-compatible irremovable metallic objects (e.g., dental prostheses, intrauterine devices, surgical implants/clips) or claustrophobia. 5. Subjects who have received any investigational drugs or participated in other clinical trials within 2 months prior to using the study medication. 6. Subjects testing positive for HIV, syphilis, or active hepatitis. 7. Positive urine toxicology (cocaine/opioids/THC/amphetamines/PCP) at screening; 8. Subjects with difficulties or contraindications to undergoing MRI scanning.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Loss of R2* signal (?R2* value);Vulnerable plaque;Plaque macrophage content (%);Vessel Wall Signal Enhancement Rate (SI%);serum iron; | — |
Secondary
| Measure | Time frame |
|---|---|
| Creatinine(Cr);Serum transferrin saturation (TFS);Serum ferritin (SF);ß 2-microglobulin (ß 2-MG);D-dimer;Retinol binding protein (RBP);Total Iron Bond Strength (TIBC);Neutrophil gelatinase associated lipocalin (NGLA);Glomerular filtration rate (eGFR);N-acetyl - ß - D-glucosaminidase (NAG); | — |
Countries
China
Contacts
Public ContactDan Mu
Shanghai Tenth People‘s Hospital
Outcome results
None listed