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Diagnostic Performance of a Novel Ferumoxytol-Enhanced Magnetic Resonance Angiography/ Venography on Panvascular Disease

NCT06136806 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-09-26

No results posted yet for this study

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 aims to answer are:

1. How about the imaging quality of FE-MRA/MRV for panvascular disease?
2. What is the diagnostic performance of FE-MRA/MRV for panvascular disease?

Participants will be divided into two groups based on their symptoms, body signs or laboratory examinations. Participants who suspected with multisite atherosclerotic diseases like coronary artery disease accompany with renal artery stenosis or peripheral arterial disease will be recruited in multisite artery disease (MAD) group. While participants who suspected with venous thromboembolism (VTE) like pulmonary embolism or deep vein thrombosis will be recruited in VTE group. Participants in MAD group will take both FE-MRA and percutaneous selective angiography measurements of coronary, renal, or lower extremity artery, while participant in VTE group need to do pulmonary artery FE-MRA and computed tomography pulmonary angiography (CTPA), lower extremity vein FE-MRV and ultrasonography.

Conditions

  • Panvascular Disease

Interventions

DIAGNOSTIC_TEST

Ferumoxytol Enhanced Magnetic Resonance Angiography（ FE-MRA）；Coronary/Renal /Lower artery Arteriography

When the patient is suspected with multisite artery disease, FE-MRA and angiography will be performed according to the patient's clinical manifestation. For example, when the patient is suspected with coronary artery disease, coronary FE-MRA and angiography will be performed; when the patient is suspected with renal artery stenosis, renal artery FE-MRA and angiography will be performed; and when the patient is suspected with the lower extremity artery occlusion, the lower extremity artery FE-MRA and angiography will be performed.

DIAGNOSTIC_TEST

Ferumoxytol Enhanced Magnetic Resonance Venography（ FE-MRV）, Computed Tomography Pulmonary Angiography, Ultrasound for Lower Extremity Deep Vein.

When the patient is suspected with venous thromboembolism, the lower extremity vein FE-MRV, pulmonary FE-MRA and ultrasound for lower extremity deep vein as well as computed tomography pulmonary angiography will be taken to ensure whether the patient with thrombus or not.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-23
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06136806 on ClinicalTrials.gov