IMaging Della PLAcca Carotidea

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Background-White matter hyperintensities (WMH), patchy areas of hyperintense signal on T2-weighted or Fluid Attenuated Inversion Recovery sequences on brain magnetic resonance imaging (MRI), are believed to reflect cerebral burden of ischemic damage and are associated to incident stroke, dementia and eventually mortality in otherwise healthy subjects. Also brain atrophy has been related with presence of carotid atherosclerosis and vascular cognitive impairment. Carotid atherosclerosis may contribute to the genesis of WMH. A recent meta-analysis by our group comprising 5306 subjects was able to demonstrate an association between the presence of carotid atherosclerosis and WMH (odds ratio, OR, 1.42, 95% confidence interval [CI] 1.22-1.66).

Objective-To evaluate the relation between carotid artery plaque characteristics, cardiovascular risk factors and brain atrophy/WMH burden analyzed quantitatively as number and volume of lesions and as brain volumes, and progression over 18 months of follow up in subjects asymptomatic for cerebrovascular disease with a carotid artery stenosis <70%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enrico Ammirati

Criteria

Inclusion Criteria:

• bearing an asymptomatic carotid stenosis of 30-70% in diameter, as established by Doppler-measured peak systolic flow velocity, according to the Society of Radiologists in Ultrasound Consensus Conference (Grant et al. Radiology 2003).

Exclusion Criteria:

• pregnancy or possibility of pregnancy,

• history of allergic diathesis,

• history of stroke or transitory ischemic attack,

• previous carotid artery stenting or carotid endarterectomy,

• history of autoimmune vasculitis,

• History of drug abuse, alcohol abuse or any psychiatric or social condition which may contraindicate the participation to a clinical study

• life expectancy of less than 18 months due to underlying medical conditions,

• presence of cognitive impairment preventing the patient from providing informed consent,

• Atrial fibrillation or previous cardiac surgery or positioning of intracardiac devices (excluded coronary stents) as potential confounding causes of cerebral ischemic damage,

• Known patent foramen ovale (PFO) necessitating anti-platelet treatment

• Current anti-coagulation,

• Previous infections to the central nervous system (CNS)

• Previous surgery to the CNS

• History of anoxic damage to the CNS

• Dementia

• Contraindications to computed tomography angiography (CTA, estimated Glomerular Filtration Rate<60 mL/min; history of allergic reaction to iodinated contrast media),

• Specific contraindication to MRI:

• Claustrophobia

• Sickle cell anemia

• Systemic mastocytosis

• Implanted cardiac devices (i.e. pacemakers, implantable cardioverter defibrillators)

• Vascular clips

• Vertebral distractors

• Infusion pumps

• Neurostimulators

• Liquor derivations

• Any device which could be dispositioned in the presence of a strong magnetic field