Testing a new MRI method for diagnosing panvascular disease

Diagnostic Performance of a Novel Ferumoxytol-Enhanced Coronary Magnetic Resonance Angiography/ Venography on Panvascular Disease: a Single-center Clinical Study.

This study is testing a new MRI method to see if it can better diagnose panvascular disease in people who might have multiple blood vessel problems.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06136806 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the diagnostic performance of ferumoxytol-enhanced magnetic resonance angiography and venography (FE-MRA/MRV) in patients suspected of having panvascular disease. Participants will be divided into two groups: one with multisite atherosclerotic diseases and another with venous thromboembolism. The study will assess imaging quality and diagnostic efficacy by comparing FE-MRA/MRV results with traditional angiography and other imaging methods. A total of 200 patients will be enrolled to provide comprehensive data on the effectiveness of this novel imaging technique.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 85 with suspected multi-site atherosclerotic vascular disease or venous thromboembolism.

Not a fit: Patients without suspected vascular diseases or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accurate and efficient diagnostic tool for patients with panvascular disease.

How similar studies have performed: While there is limited data on the specific use of ferumoxytol in this context, other studies have shown promise in using advanced MRI techniques for vascular imaging.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 85 years;
2. Those with suspected multi-site atherosclerotic vascular disease (MAD) (fulfilling both a), and at least two of b), c), and d)):

   1. have at least 1 risk factor for atherosclerosis (hypertension, diabetes mellitus, hyperlipidemia, smoking, and obesity);
   2. Those with suspected coronary atherosclerotic cardiovascular disease: angina symptoms, ST-T changes on ECG;
   3. those with suspected atherosclerotic renal artery stenosis: periumbilical vascular murmur, intractable hypertension, renal insufficiency difficult to explain by other causes;
   4. Those with suspected atherosclerotic lower extremity peripheral arterial disease: intermittent claudication, diminished or absent dorsalis pedis arterial pulses.
3. Those with suspected venous thromboembolism (VTE) (fulfill at least one of a) and b)):

   1. Those with suspected DVT: swelling and pain in the lower extremities;
   2. Those with suspected PE: simplified Wells score ≥ 1.
4. Patients sign an informed consent form.

Exclusion Criteria:

1. Those who are allergic to iodine contrast media or have a history of allergy or hypersensitivity to iron or dextrose;
2. 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);
3. Those with terminal illness (e.g., suffering from malignant tumors) or with a life expectancy of \<1 year;
4. Liver insufficiency (alanine aminotransferase \> 3 times the upper limit of normal value);
5. Renal insufficiency (eGFR \<30mL/min/1.73cm2);
6. Hyperthyroidism;
7. Those with hemodynamic instability;
8. Pregnant and lactating women;
9. Persons with hearing limitations;
10. Persons with cardiac function class III-IV;
11. Persons on other oral or intravenous iron supplements;
12. Patients with ferrous hemosiderin deposition or hemochromatosis;
13. Patients with acute coronary syndromes;
14. Any other person who, in the opinion of the investigator, should not participate in this study.

Where this trial is running

Nanjing, Jiangsu

• First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Conditions Panvascular Disease; Magnetic Resonance Imaging; Ferumoxytol