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:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT03291093
Eligibility Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* All patients:
* Age18years and older (no maximum age)
* Informed consent by signed informed consent form regarding this study
* Patients, who are scheduled for carotid endarterectomy:
o Inclusion criteria for carotid endarterectomy:
* Symptomatic stenosis (TIA or CVA) within last 14days and high grade stenosis (70-99%)
* In men, carotid artery stenosis between 50-69% is considered significant when related to clinical symptoms
* Patients, who are not scheduled for carotid endarterectomy:
* Patients who have experienced a TIA/CVA/amaurosis fugax (a 'TIA of the eye') within the last 14 days and abnormal findings on imaging of the carotids:
* Women with an ipsilateral carotid artery stenosis between 30-69% based on duplex ultrasonography, CTA, or MRA
* Men with an ipsilateral carotid artery stenosis between 30-49% based on duplex ultrasonography, CTA, or MRA
* Patients meeting inclusion criteria for carotid endarterectomy, but with contra- indications for CEA
Exclusion Criteria:
* All patients:
* Severe cognitive impairment, neurological deficit or comorbidity causing the study to be too high a burden for the patient or disrupting patient's co- operation with scan procedures
* Evident other causality for stroke (cardiac embolus, small vessel disease or thrombogenic diathesis)
* Pregnant women and nursing mothers
* Contra-indications for MRI (49):
* Ferromagnetic implants, such as pacemakers and other electronic implants
* Ferromagnetic (intracerebral) vascular clips
* Metallic cochlear implants
* Metallic splinters in eye(s) or other magnetic metallic foreign bodies elsewhere
* Claustrophobia
* Relative contra-indications for MRI-contrast agents (50):
* GFR \<30ml/min/1,73m2
* Previous allergic reaction to MRI contrast agent
* Contra-indication 18F-Flutemetamol:
* Known allergic reaction to flutemetamol or polysorbate 80 or any of the excipients.
* Severe liver dysfunction.
* Patients undergoing CEA:
* Comorbidity associated with high operative risk
* Occlusion of the internal carotid artery on the symptomatic side
* Near occlusion on the symptomatic side
* Complete infarction of the symptomatic anterior circulation/severe neurological deficit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03291093
Study Brief:
Protocol Section:
NCT03291093