Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT01674257
Eligibility Criteria:
Inclusion Criteria:
* Patients with carotid stenosis due to undergo carotid endarterectomy.
Exclusion Criteria:
* Patients with new stroke and a modified Rankin score \>3
* Chronic Kidney Disease with eGFR of \<30 mL/min/1.73m2
* Pregnant women
* Poorly controlled diabetes mellitus (HbA1c \> 8.5%) or diabetes mellitus requiring insulin
* Prior ipsilateral carotid intervention
* Prior neck irradiation
* Inability to tolerate the supine position
* Participation in the study would result in delay to surgery
* Psychiatric illness/social situations that would limit compliance with study requirements
* Specific contraindications to MRI (e.g. pacemaker)
* History of allergic reaction attributed to ferumoxytol or similar
* Known or suspected iron overload (genetic haemochromatosis or history of multiple transfusions)
* History of allergic reaction attributed to 18F-FDG or 18F-NaF or similar
* History of allergic reaction to iodine or iodine-based contrast media
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01674257
Study Brief:
Protocol Section:
NCT01674257