drugset / Trial / NCT03333330

IMaging Della PLAcca Carotidea

NCT03333330

Phase 3 Completed 75 enrolled Enrico Ammirati
NaSingle-groupOpen-labelDiagnostic

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%.

Timeline

Start
2012-04
Primary completion
2017-10
Completion
2017-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Background Iodixanol Diagnostic / imaging agent 320 mg/ml
Background Sodium hexafluoride Diagnostic / imaging agent