Status:
UNKNOWN
18F-Flutemetamol and Plaque Vulnerability
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Rationale: Amyloid beta (Ab) is mainly known for its role in Alzheimer's disease (AD) pathology. However, Ab seems not only to be involved in AD pathology, but also in atherosclerosis, which might exp...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03291093
Start Date
February 1 2018
End Date
December 31 2019
Last Update
July 11 2019
Active Locations (1)
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1
Maastricht University Medical Centre (MUMC+)
Maastricht, Limburg, Netherlands, 6229 HX