Ferumoxytol-enhanced Magnetic Resonance Imaging

NCT02954510 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 2016P000250
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

  48 months

Secondary Outcomes (2)

• Detect stenosis in proximal and distal segments of the coronary artery tree

  48 months

• Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography

  48 months

Study Arms (1)

Intervention

EXPERIMENTAL

Single arm utilizing ferumoxytol

Drug: ferumoxytol

Interventions

ferumoxytol DRUG

ferumoxytol will assess patency of coronary arteries

Also known as: feraheme

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Chin MS, Steigner M, Yin W, Kwong RY, Siedlecki AM. Intraluminal Assessment of Coronary Arteries With Ferumoxytol-Enhanced Magnetic Resonance Angiography. JACC Cardiovasc Imaging. 2018 Mar;11(3):505-508. doi: 10.1016/j.jcmg.2017.10.017. Epub 2017 Dec 13. No abstract available.

  PMID: 29248659 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Experts evaluating ferumoxytol-enhanced magnetic resonance imaging will be masked to the results of other invasive and non-invasive cardiac testing
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: case control

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: November 3, 2016
• Study Start: February 1, 2017
• Primary Completion: November 1, 2023
• Study Completion: February 27, 2024
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within one year of the conclusion of the study. Data will be available for at least seven years.

Locations

US (1)