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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Time Frame
Start Date: 2024-02-23
Estimated Completion Date: 2025-01-30
Participants
Target number of participants: 200
Treatments
Multisite Artery Disease (MAD) Group
Participants in MAD group mean these patients are suspected with multisite artery disease, like coronary artery disease accompany with renal artery stenosis or lower extremity atherosclerosis.
Venous Thromboembolism (VTE)Group
Participants in VTE group mean these patients are suspected with deep vein thrombosis or pulmonary embolism.
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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