Ferumoxytol-enhanced Magnetic Resonance Imaging

Coronary Artery Disease Clinical Trial

Official title:

Ferumoxytol-enhanced Magnetic Resonance Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348524
• Other study ID #: ferumoxytol_2015
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 3, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Transmed Solutions
• Contact: Andrew M Siedlecki, MD
• Phone: 3142432143
• Email: andrewsiedlecki[@]trnsmdsltns.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are no current alternatives to diagnostic contrast-requiring imaging for patients with an eGFR <30mL/min due to the association of gadolinium-based imaging modalities to nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury. Ferumoxytol-enhanced imaging may offer an alternative approach.

Description:

This is a case control study which will assess the resolution by which the coronary arteries can be visualized using ferumoxytol-enhanced cardiac magnetic resonance angiography (fcMRA) in patients with prior regional cardiac ischemia localized by stress-induced echocardiography. Resolution will be compared to invasive coronary arteriography completed in all patients that will be analyzed at the end of the study.

Masked experts will interpret fcMRA images to determine if coronary stenosis is present or absent. By strict definitions, this is a single-arm study. However comparison will be made between fcMRA and invasive coronary arteriography performed in each patient. With a prevalence of disease of approximately 0.35 in the study population, it is anticipated that both sensitivity and specificity of fcMRA to identify the absence of coronary artery stenosis can be calculated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Both female and male participants are being studied aged 18-85 years old with an estimated glomerular filtration rate (eGFR) of less than 30ml/min/1.73 meters squared. Patients will have undergone cardiac screening tests that warrant further evaluation. Patients will be excluded with an eGFR >30ml/min/1.73 meters squared.

Inclusion criteria:

Diagnosis of chronic kidney disease Diagnosis of anemia of chronic kidney disease

Exclusion criteria:

Hypersensitivity to intravenous iron products

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Ferumoxytol injection
ferumoxytol will assess patency of coronary arteries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Transmed Solutions

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detect the absence of =50% stenosis in the coronary artery tree	This outcome derives from the central hypothesis which states that coronary artery disease can more effectively be excluded in patients with severe chronic kidney disease using ferumoxtyol enhanced cardiac magnetic resonance angiography (fcMRA) rather than non-invasive cardiac testing combined with ICA. The presence or absence of a single 50% stenosis in the region of interest (measured as described above) will be dichotomized (0=absent/ 1= present) from each of the two measures, fcMRA and invasive coronary arteriography	12 months
Secondary	Detect stenosis in proximal and distal segments of the coronary artery tree	The purpose of this secondary outcome is to determine the sensitivity and specificity of fcMRA to detect the absence of lesions exhibiting =50% stenosis compared to ICA in proximal and distal arterial segments	12 months
Secondary	Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography	The purpose of this secondary outcome is to determine the sensitivity and specificity of fcMRA to dobutamine stress echocardgiography testing in the assessment of coronary artery stenosis when compared to ICA.	12 months