Ferumoxytol-enhanced Magnetic Resonance Imaging

Phase 3

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Drug: Ferumoxytol injection

• Registration Number: NCT06348524
• Lead Sponsor: Transmed Solutions

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-31
• Last Update Submitted: 2024-03-31
• Study First Posted: 2024-04-04
• Last Update Posted: 2024-04-04
• Study Start: 2024-08-03
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm utilizing ferumoxytol	Ferumoxytol injection	-

Primary Outcome Measures

Name	Time	Method
Detect the absence of ≥50% stenosis in the coronary artery tree	12 months	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

Secondary Outcome Measures

Name	Time	Method
Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography	12 months	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.
Detect stenosis in proximal and distal segments of the coronary artery tree	12 months	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