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Panvascular DiseaseNCT06136806

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

An observational study of Panvascular Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Panvascular Disease
What is being tested?
Ferumoxytol Enhanced Magnetic Resonance Angiography（ FE-MRA）；Coronary/Renal /Lower artery Arteriography and Ferumoxytol Enhanced Magnetic Resonance Venography（ FE-MRV）, Computed Tomography Pulmonary Angiography, Ultrasound for Lower Extremity Deep Vein.
How many people
200 participants
Where
1 siteChina
Study dates
23 Feb 2024to 30 Jan 2025
How long will I take part?
1 Week
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study adopts a continuous enrollment method. It is estimated that 200 suspected pan-vascular disease patients will be enrolled within the study period.

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210000

    Li chunjian, Phd、MD, +86 13701465229, lijay@njmu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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. 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.

Being tested
Ferumoxytol Enhanced Magnetic Resonance Angiography（ FE-MRA）；Coronary/Renal /Lower artery Arteriography, Ferumoxytol Enhanced Magnetic Resonance Venography（ FE-MRV）, Computed Tomography Pulmonary Angiography, Ultrasound for Lower Extremity Deep Vein.
Keywords
Magnetic Resonance Imaging, Ferumoxytol, Panvascular Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  • 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.

Study groups in NCT06136806
Study groupRoleWhat they receive
Multisite Artery Disease (MAD) GroupParticipants 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.
Receives: Diagnostic Test: Ferumoxytol Enhanced Magnetic Resonance Angiography（ FE-MRA）；Coronary/Renal /Lower artery Arteriography
Venous Thromboembolism （VTE）GroupParticipants in VTE group mean these patients are suspected with deep vein thrombosis or pulmonary embolism.
Receives: Diagnostic Test: Ferumoxytol Enhanced Magnetic Resonance Venography（ FE-MRV）, Computed Tomography Pulmonary Angiography, Ultrasound for Lower Extremity Deep Vein.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the degree of coronary/ renal/lower extremity artery stenosis

    Degree of artery stenosis assessed by FE-MRA and percutaneous selective angiography.

    Measured: 1 week

  2. 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.

    Measured: 1 week

  3. Pulmonary Embolism

    FE-MRA and computed tomography pulmonary angiography will be taken to evaluate whether there is pulmonary embolism or not.

    Measured: 1 week

  4. Image quality of FE-MRA/MRV

    The image quality will be assessed by a 4-point scale:

    1. poor (vessel barely evident or noisy image);
    2. moderate (vessel visible but diagnostic confidence low);
    3. good (vessel adequately visualized and diagnostic quality image);
    4. excellent (vessel clearly depicted)

    Measured: 1 week

  5. signal-to-noise ratio （SNR）

    An indicator represents for image quality.

    Measured: 1 week

  6. contrast-to-noise ratio (CNR)

    An indicator represents for image quality.

    Measured: 1 week

  7. below-knee artery occlusion

    Whether below-knee arteries occlusion or not assessed by FE-MRA and percutaneous selective angiography .

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start23 Feb 2024
  3. Primary completion30 Jan 2025 (estimated)
  4. Study completion30 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT06136806
Sponsor's protocol ID
027
Status last verified
Nov 2023
First submitted
13 Nov 2023
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35078371

  • Esmatjes E, Blanco AJ. [The REACH registry: baseline and 1-year results]. Med Clin (Barc). 2009 Sep;132 Suppl 2:5-9. doi: 10.1016/S0025-7753(09)71745-2. Spanish.

    PubMed 19631831

  • Pan Y, Jing J, Cai X, Jin Z, Wang S, Wang Y, Zeng C, Meng X, Ji J, Li L, Lyu L, Zhang Z, Mei L, Li H, Li S, Wei T, Wang Y. Prevalence and Vascular Distribution of Multiterritorial Atherosclerosis Among Community-Dwelling Adults in Southeast China. JAMA Netw Open. 2022 Jun 1;5(6):e2218307. doi: 10.1001/jamanetworkopen.2022.18307.

    PubMed 35759265

  • Di Noi P, Brancati MF, Burzotta F, Trani C. Multisite artery disease: a common and challenging clinical condition calling for specific management. Future Cardiol. 2014 May;10(3):395-407. doi: 10.2217/fca.14.25.

    PubMed 24976476

  • Zhang Q, Wang A, Zhang S, Li N, Chen S, Zhang Y, Zhou Y, Wu S, Zhao X. Asymptomatic polyvascular disease and the risks of cardiovascular events and all-cause death. Atherosclerosis. 2017 Jul;262:1-7. doi: 10.1016/j.atherosclerosis.2017.04.015. Epub 2017 Apr 21.

    PubMed 28463782

  • Doherty S. Pulmonary embolism An update. Aust Fam Physician. 2017 Nov;46(11):816-820.

    PubMed 29101916

  • Mezquita AJV, Biavati F, Falk V, Alkadhi H, Hajhosseiny R, Maurovich-Horvat P, Manka R, Kozerke S, Stuber M, Derlin T, Channon KM, Isgum I, Coenen A, Foellmer B, Dey D, Volleberg RHJA, Meinel FG, Dweck MR, Piek JJ, van de Hoef T, Landmesser U, Guagliumi G, Giannopoulos AA, Botnar RM, Khamis R, Williams MC, Newby DE, Dewey M. Clinical quantitative coronary artery stenosis and coronary atherosclerosis imaging: a Consensus Statement from the Quantitative Cardiovascular Imaging Study Group. Nat Rev Cardiol. 2023 Oct;20(10):696-714. doi: 10.1038/s41569-023-00880-4. Epub 2023 Jun 5.

    PubMed 37277608

  • Zeng Y, He R, Ren Y, Che Y, Wang G. Cervicocerebral Computed Tomography Angiography for Older Patients Based on Time to Peak and Number of Time Points to Peak in the Test Bolus Technique. J Comput Assist Tomogr. 2023 Jan-Feb 01;47(1):165-172. doi: 10.1097/RCT.0000000000001396. Epub 2022 Dec 13.

    PubMed 36668985

  • Briley-Saebo KC, Cho YS, Shaw PX, Ryu SK, Mani V, Dickson S, Izadmehr E, Green S, Fayad ZA, Tsimikas S. Targeted iron oxide particles for in vivo magnetic resonance detection of atherosclerotic lesions with antibodies directed to oxidation-specific epitopes. J Am Coll Cardiol. 2011 Jan 18;57(3):337-47. doi: 10.1016/j.jacc.2010.09.023. Epub 2010 Nov 23.

    PubMed 21106318

  • Corot C, Robert P, Idee JM, Port M. Recent advances in iron oxide nanocrystal technology for medical imaging. Adv Drug Deliv Rev. 2006 Dec 1;58(14):1471-504. doi: 10.1016/j.addr.2006.09.013. Epub 2006 Sep 30.

    PubMed 17116343

  • Spinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJ. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008 Aug;19(8):1599-605. doi: 10.1681/ASN.2007101156. Epub 2008 Jun 4.

    PubMed 18525001

  • Lehrman ED, Plotnik AN, Hope T, Saloner D. Ferumoxytol-enhanced MRI in the peripheral vasculature. Clin Radiol. 2019 Jan;74(1):37-50. doi: 10.1016/j.crad.2018.02.021. Epub 2018 May 3.

    PubMed 29731126

  • Finn JP, Nguyen KL, Hu P. Ferumoxytol vs. Gadolinium agents for contrast-enhanced MRI: Thoughts on evolving indications, risks, and benefits. J Magn Reson Imaging. 2017 Sep;46(3):919-923. doi: 10.1002/jmri.25580. Epub 2017 Feb 3. No abstract available.

    PubMed 28160356

  • Gahramanov S, Raslan AM, Muldoon LL, Hamilton BE, Rooney WD, Varallyay CG, Njus JM, Haluska M, Neuwelt EA. Potential for differentiation of pseudoprogression from true tumor progression with dynamic susceptibility-weighted contrast-enhanced magnetic resonance imaging using ferumoxytol vs. gadoteridol: a pilot study. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):514-23. doi: 10.1016/j.ijrobp.2009.10.072. Epub 2010 Apr 13.

    PubMed 20395065

  • Neuwelt EA, Hamilton BE, Varallyay CG, Rooney WR, Edelman RD, Jacobs PM, Watnick SG. Ultrasmall superparamagnetic iron oxides (USPIOs): a future alternative magnetic resonance (MR) contrast agent for patients at risk for nephrogenic systemic fibrosis (NSF)? Kidney Int. 2009 Mar;75(5):465-74. doi: 10.1038/ki.2008.496. Epub 2008 Oct 8.

    PubMed 18843256

Questions about this trial

What is this clinical trial studying?

An observational study of Panvascular Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the degree of coronary/ renal/lower extremity artery stenosis (time frame: 1 week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06136806, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.

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