This study was designed to whether there is a measurable reduction in inflammation in walls of unruptured vertebrobasilar dissecting aneurysms with atorvastatin.
Unruptured vertebrobasilar dissecting aneurysms (UVBDAs) are a pathological condition of the vertebrobasilar artery caused by hypertension, atherosclerosis, and infection. Hematoma between intima and media can progressively occlude the parent artery. Thus lead to decreasing perfusion of the distal perforator vessels and even cause cerebral infarction. Even worse, ruptured VBDAs can lead to subarachnoid hemorrhage and eventually death of the patients. Thus, risk of UVBDAs rupture should be weighed, and need an individual criterion for predicting rupture in clinical decision making. Recently, many histopathological studies indicated that inflammation may play an important role in the formation, growth, and rupture of aneurysms. High-resolution vessel wall MRI (HR-VW-MRI) has been increasingly applied in clinical practice and is the only noninvasive method for imaging the structure of the vascular wall. Wall enhancement of an aneurysm on high resolution magnetic resonance (HRMRI) is a proven sign of inflammatory change and might predict an unsteady state of an intracranial aneurysm. Besides, a previous study has demonstrated that HR-MRI can provide valuable information, such as parameters of intramural hematomas, double lumens and intimal flaps, in the diagnosis and follow-up UVBDAs. Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are widely used cholesterol-lowering drugs and are established as first-line treatments for hypercholesterolemia. In addition, statins exert pleiotropic effects to protect the vasculature. Statins can reduce the inflammation of the vessel wall and mobilize endothelial progenitor cells for aneurysmal endothelial cell repair. Statins can also inhibit the expression of several matrix metalloproteinases by smooth muscle cells and macrophages, which may be important in reducing the growth and rupture of UVBDAs. In this study, participants with UVBDAs that are not planned for surgical treatment and has not yet ruptured, take atorvastatin daily for six months, and have a HRMRI scan before and after conservative therapy to look for the role of atorvastatin in inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Enrollment
40
One with the intervention (Atorvastatin, 20mg OD), 20 patients for this arm.
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGMirzat Turhon
Beijing, China
NOT_YET_RECRUITING1.Change of aneurysm wall inflammation as measured by HR-VW-MRI.
Change of aneurysm wall enhancement index of at least 20% on HR-VM-MRI at the end of 6 months of atorvastatin 20mg daily treatment, compared to no treatment.
Time frame: 6 months
Change of aneurysmal morphology parameter (the largest diamater)
Change of aneurysmal morphology parameter between pre-treatment and the 6 months follow-up periods.
Time frame: 6 months
Change of wall features of UVBDAs
Change of wall features of UVBDAs, which is intramural hematoma between pre-treatment and the 6 months follow-up periods. (The maximum diameter of the false lumen was compared)
Time frame: 6 months
Change of inflammatory markers in UVBDAs patients
Change of inflammatory markers in UVBDAs patients between pre-treatment and the 6 months follow-up periods. (CRP, TNF alpha, IL-2,6,8,10 and IL-1 beta)
Time frame: 6 months
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