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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:
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.
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. Clinical tests of the suspected population are often carried out by parts and times, and there is no one-stop, panoramic examination on panvascular disease.
Ferumoxytol is a novel and safe MRI contrast agent with an intravascular half-life of approximately 15 hours, enabling simultaneous scanning of multiple sites. At this background, our study intends to investigate the diagnostic efficacy of FE-MRA/MRV in panvascular diseases.
In this study, we plan to enroll 200 patients with suspected panvascular disease. Patients with suspected coronary artery disease, renal artery stenosis, or lower extremity arterial disease will be included in the MAD group, and patients with suspected pulmonary artery embolism and lower extremity venous embolism will be included in the VTE group.
In the MAD group, patients will take both FE-MRA and percutaneous selective angiography of coronary, renal, or lower extremity artery. We will record the FE-MRA image quality score, signal to noise ratio(SNR), compare signal-to-noise ratio(CNR), whether the coronary, renal, and lower extremity arteries have stenosis greater than 50%, and whether the below-knee arteries are occluded. In the VTE group, patients need to do pulmonary artery FE-MRA and computed tomography pulmonary angiography (CTPA), lower extremity vein FE-MRV and ultrasonography. We will record the image quality scores of FE-MRA of the pulmonary arteries, the FE-MRV the lower extremities, SNR, CNR, the presence of pulmonary embolism or deep vein thrombosis.
The sensitivity, specificity, positive predictive value, and negative predictive value of FE-MRA for the diagnosis of arteries stenosis >50% will be evaluated by using percutaneous selective angiography as the gold standard and generating subject operating characteristic (ROC) curves. And the sensitivity, specificity, positive predictive value, and negative predictive value of FE-MRA/MRV for the diagnosis of thrombosis in the pulmonary artery or lower extremities will be evaluated by generating ROC curves by using CTPA and venous ultrasound as the reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol Enhanced Magnetic Resonance Angiography( FE-MRA);Coronary/Renal /Lower artery Arteriography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the degree of coronary/ renal/lower extremity artery stenosis | Degree of artery stenosis assessed by FE-MRA and percutaneous selective angiography. | 1 week |
| Deep Vein Thrombosis | FE-MRV and ultrasound for lower extremity deep vein will be taken to evaluate whether there is deep vein thrombosis or not. | 1 week |
| Pulmonary Embolism | FE-MRA and computed tomography pulmonary angiography will be taken to evaluate whether there is pulmonary embolism or not. | 1 week |
| Image quality of FE-MRA/MRV | The image quality will be assessed by a 4-point scale:
| 1 week |
| signal-to-noise ratio (SNR) | An indicator represents for image quality. | 1 week |
| contrast-to-noise ratio (CNR) | An indicator represents for image quality. | 1 week |
| below-knee artery occlusion | Whether below-knee arteries occlusion or not assessed by FE-MRA and percutaneous selective angiography . | 1 week |
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Inclusion Criteria:
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)):
Those with suspected venous thromboembolism (VTE) (fulfill at least one of a) and b)):
Patients sign an informed consent form.
Exclusion Criteria:
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This study adopts a continuous enrollment method. It is estimated that 200 suspected pan-vascular disease patients will be enrolled within the study period.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35078371 | Background | Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26. | |
| 19631831 |
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| Ferumoxytol Enhanced Magnetic Resonance Venography( FE-MRV), Computed Tomography Pulmonary Angiography, Ultrasound for Lower Extremity Deep Vein. | Diagnostic Test | 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. |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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