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Clinical Trials/NCT03940859
NCT03940859
Unknown
Not Applicable

Investigation of Dynamic Contrast-Enhanced Magnetic Resonance Imaging Analysis Predicting Prognosis of Intracranial Dissecting Aneurysm With Intramural Hematoma After Endovascular Treatment

Beijing Neurosurgical Institute1 site in 1 country80 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dissecting Aneurysm of Cerebral Artery
Sponsor
Beijing Neurosurgical Institute
Enrollment
80
Locations
1
Primary Endpoint
neovascularization and permeability factors related to enlargement of IMH as assessed by DCE-MRI.
Last Updated
6 years ago

Overview

Brief Summary

This study will evaluate the feasibility to predict the prognosis of IDA with IMH by DCE-MRI and provide theoretical basis for the prognosis and intervention of the disease.

Detailed Description

Intracranial dissecting aneurysm (IDA) was a challenging disease and could result in stroke in young and middle-aged adults. Intramural hematoma, one of the typical imaging findings of IDA, can grow continuously in untreated IDA. Due to relatively high complication rate associated with surgical procedures, endovascular treatments have become the first-line therapy for such lesions. According to whether the parent artery was maintained, endovascular treatment was divided into deconstructive (proximal arterial occlusion and internal trapping) and reconstructive (stent implantation with or without coiling) techniques . However, recanalization of IDA was a great challenge for endovascular treatment and influenced the prognosis of patients. The formation of an IMH is a critical event in the progress of IDA and IDA may grow because of recurrent IMH even after deconstructive endovascular treatment. Increased IMH size could result in severe compression symptoms or even death. At present, the mechanism of the continuous growth of intramural hematoma after endovascular treatment of IDA is still unclear. Some authors believe that the continuous hemorrhage of the vasa vasorum in the IMH results in the continuous enlargement of the IMH. However, this theory has not been proved by imaging in vivo. Dynamic contrast-enhanced magnetic resonance imaging analysis for prognosis of intracranial dissecting aneurysm with intramural hematoma after endovascular treatment (DEMAT) is a prospective trial designed to collect a large series of patients with IDAs treated endovascularly to predict the prognosis of IDA with IMH by DCE-MRI and provide theoretical basis for the prognosis and intervention of the disease.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
December 31, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

zhangyisen

Attending Doctor of Department of Interventional Neuroradiology

Beijing Neurosurgical Institute

Eligibility Criteria

Inclusion Criteria

  • adult patients (age 18-80 years) patients' ability to cooperate during the MRI examination; patients who are were diagnosed with IDA according to DSA and MRI; expectation of adequate patient safety during these examinations; unequivocal evidence by MRI (IMH\>5 mm on the perpendicular plane to the long axis of the vessel) of IDA; IDA treated by the endovascular approach; patients' willingness to participate in the study.

Exclusion Criteria

  • patients with pre-existing diagnoses of arteritis, fibromuscular dysplasia, iatrogenic aneurysms or pseudoaneurysms; extracranial dissecting aneurysms extended into the intracranial segment; patients with other diseases or poor general condition with expected survival of less than 2 year; the IDA has already been treated by the endovascular treatment; patients lacking DCE-MRI follow up.

Outcomes

Primary Outcomes

neovascularization and permeability factors related to enlargement of IMH as assessed by DCE-MRI.

Time Frame: 6 months

Using DCE-MRI, the parameters as Ktrans and Vp could be calculated and analyzed. These will be studied as a composite indicator for the enlargement of IMH.

Secondary Outcomes

  • clinical factors related to the enlargement of IMH as recorded from medical chart(6 months)

Study Sites (1)

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