Dynamic Contrast-Enhanced Magnetic Resonance Imaging Analysis for Prognosis of Intracranial Dissecting Aneurysm With Intramural Hematoma After Endovascular Treatment (DEMAT)
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|ClinicalTrials.gov Identifier: NCT03940859|
Recruitment Status : Unknown
Verified July 2019 by zhangyisen, Beijing Neurosurgical Institute.
Recruitment status was: Recruiting
First Posted : May 7, 2019
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment|
|Dissecting Aneurysm of Cerebral Artery||Device: intracranial stent, flow diverter and coils|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||80 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Investigation of Dynamic Contrast-Enhanced Magnetic Resonance Imaging Analysis Predicting Prognosis of Intracranial Dissecting Aneurysm With Intramural Hematoma After Endovascular Treatment|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Patients with intramural hematoma in intracranial dissecting aneurysm treated by endovascular treatment will be recruited.
Device: intracranial stent, flow diverter and coils
Endovascular treatment was performed under general anesthesia. Patients were treated with internal trapping, stent-assisted coiling or flow diverter as appropriate. After the procedure, patients treated with conventional stent were given 75mg/d clopidogrel for 6 weeks and 100mg/d aspirin for 6months, while patients treated with flow diverter were given 75mg/d clopidogrel for 3 months and 100mg/d aspirin thereafter. All patients were recommended to undergo a 6-month angiographic follow-up.
- 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.
- clinical factors related to the enlargement of IMH as recorded from medical chart [ Time Frame: 6 months ]size, treatment method, device use, follow-up interval, smoke history, hypertension, et al, will be recorded and analyzed.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940859
|Contact: Yisen Zhang, Dr.||+email@example.com|
|Beijing Neurosurgical Institute and Beijing Tiantan Hospital||Recruiting|
|Beijing, Beijing, China, 100070|
|Contact: Yisen Zhang, Dr. +86-010-59978852 firstname.lastname@example.org|