Dynamic Contrast-Enhanced Magnetic Resonance Imaging Analysis for Prognosis of Intracranial Dissecting Aneurysm With Intramural Hematoma After Endovascular Treatment (DEMAT)

July 17, 2019 updated by: zhangyisen, Beijing Neurosurgical Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Neurosurgical Institute and Beijing Tiantan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients had an IDA with IMH and received an endovascular treatment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DEMAT
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.
Other Names:
  • Low profile Visualized Intraluminal Device (LVIS)
  • Pipeline™(or Flex) Embolization Device(PED)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Neurosurgical Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

May 5, 2019

First Submitted That Met QC Criteria

May 5, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSFC-81801158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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