Moya Moya Syndrome With or Withtout Sickle Cell Disease (BMM-ScD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05050344|
Recruitment Status : Recruiting
First Posted : September 20, 2021
Last Update Posted : September 24, 2021
Moya Moya disease or syndrome ar characterized by a progressive or occlusion of the intracranial carotid arteries and their mainproximal branches, followed by the development of fragile neovessels at the base of the skull, leding to a high risk of both ischemic and hemorragic stroke over time. Moya Moya syndrome are associated to a variety of disease, which main frequent is sickle cell disease (SCD).
Among patients with SCD who had suffered from at least one ischemic stroke, the prevalence of moya moya syndrome was estimated up to 43%. In general, therapeutic strategies in Moya Moya to prevent first ever ou recurrent stroke can be divided into conservative medical treatment and surgical revascularisation (direct bypass, indirect bypass or combined bypass).
The aim of this study is to compare prognosis of patients with Moya Moya syndrome associated with sickle cell disease or not. The investigators retrospectiveluy analysed medical chart from 2010 to 2021 of patients with Moya Moya disease or syndrome at two French university hospitals (including a center of the french West Indies where prevalence of sickle cell disease is high). The diagnosis was based on angiography or MRI records showing uni- or bilateral stenosis of distal intracranial internal carotide arteries or middle cerebral arteries associated wirh classic collateral network.
Main endpoint will be comparison of a composite outcome defined as time from Moya Moya diagnosis to first or recurrent stroke or bad prognosis achivement (defined by modified Rankin score >2)
|Condition or disease|
|Moya Moya Disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Descriptive Bicentric Study of Moya Moya Syndrome and Disease in Sickle Cell Disease Patients and Not Sickle Cell Disease|
|Actual Study Start Date :||May 1, 2021|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2022|
- time from Moya Moya diagnosis to first or recurrent stroke or bad prognosis achivement [ Time Frame: 1 day ]composite endpoint of outcome defined as time from Moya Moya diagnosis to first or recurrent stroke or bad prognosis achivement (defined by modified Rankin score >2)
- Time from MM diagnosis to Stroke [ Time Frame: 1 day ]Time from MM diagnosis to Stroke
- poor prognosis or death [ Time Frame: 1 day ]poor prognosis or death (mRS> 2) at the last clinical evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05050344
|Contact: Nicolas Gaillard, MD||4 67 33 74 13 ext email@example.com|
|Montpellier, France, 34295|
|Contact: Nicolas Gaillard, MD 4 67 33 74 13 ext 33 firstname.lastname@example.org|
|Contact: Estelle Brithmer e-Brithmer@chu-montpellier.fr|
|Principal Investigator:||Estelle BRITHMER, Resident||University Hospital, Montpellier|