Status:
UNKNOWN
Diagnostic Performance of a Novel Ferumoxytol-Enhanced Magnetic Resonance Angiography/ Venography on Panvascular Disease
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Panvascular Disease
Eligibility:
All Genders
18-85 years
Brief Summary
The goal of this observational study is to test the diagnostic performance of ferumoxytol-enhanced magnetic resonance angiography/ venography（FE-MRA/MRV） on panvascular disease. The main questions it ...
Detailed Description
Panvascular disease refers to multi-site vascular disease, presenting as multi-site atherosclerotic disease and venous thromboembolism. There is no gold standard test for panvascular disease up to now...
Eligibility Criteria
Inclusion
- Age 18 to 85 years;
- Those with suspected multi-site atherosclerotic vascular disease (MAD) (fulfilling both a), and at least two of b), c), and d)):
- have at least 1 risk factor for atherosclerosis (hypertension, diabetes mellitus, hyperlipidemia, smoking, and obesity);
- Those with suspected coronary atherosclerotic cardiovascular disease: angina symptoms, ST-T changes on ECG;
- those with suspected atherosclerotic renal artery stenosis: periumbilical vascular murmur, intractable hypertension, renal insufficiency difficult to explain by other causes;
- Those with suspected atherosclerotic lower extremity peripheral arterial disease: intermittent claudication, diminished or absent dorsalis pedis arterial pulses.
- Those with suspected venous thromboembolism (VTE) (fulfill at least one of a) and b)):
- Those with suspected DVT: swelling and pain in the lower extremities;
- Those with suspected PE: simplified Wells score ≥ 1.
- Patients sign an informed consent form.
Exclusion
- Those who are allergic to iodine contrast media or have a history of allergy or hypersensitivity to iron or dextrose;
- Those who are unable to undergo MRI due to psychological (e.g., suffering from claustrophobia syndrome) or physical reasons (e.g., retention of metallic objects in the body);
- Those with terminal illness (e.g., suffering from malignant tumors) or with a life expectancy of \<1 year;
- Liver insufficiency (alanine aminotransferase \> 3 times the upper limit of normal value);
- Renal insufficiency (eGFR \<30mL/min/1.73cm2);
- Hyperthyroidism;
- Those with hemodynamic instability;
- Pregnant and lactating women;
- Persons with hearing limitations;
- Persons with cardiac function class III-IV;
- Persons on other oral or intravenous iron supplements;
- Patients with ferrous hemosiderin deposition or hemochromatosis;
- Patients with acute coronary syndromes;
- Any other person who, in the opinion of the investigator, should not participate in this study.
Key Trial Info
Start Date :
February 23 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06136806
Start Date
February 23 2024
End Date
January 30 2025
Last Update
September 26 2024
Active Locations (1)
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1
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000