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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
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





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Time from MM diagnosis to Stroke [ Time Frame: 1 day ]
    Time from MM diagnosis to Stroke

  2. poor prognosis or death [ Time Frame: 1 day ]
    poor prognosis or death (mRS> 2) at the last clinical evaluation.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients >=15 years of age at diagnosis of Moya Moya disease and syndrome from january 2010 to february 2021 at Montpellier and Martinique University Hospital
Criteria

Inclusion criteria:

  • age >=15
  • patients at diagnosis of Moya Moya disease and syndrome

Exclusion criteria:

  • misclassified patients
  • clinical diagnosis of MM not confirmed by angiography or MRI

Information from the National Library of Medicine

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


Contacts
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Contact: Nicolas Gaillard, MD 4 67 33 74 13 ext 33 n-gaillard@chu-montpellier.fr

Locations
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France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: Nicolas Gaillard, MD    4 67 33 74 13 ext 33    n-gaillard@chu-montpellier.fr   
Contact: Estelle Brithmer    e-Brithmer@chu-montpellier.fr      
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Estelle BRITHMER, Resident University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT05050344    
Other Study ID Numbers: RECHMPL21_0343
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Moya Moya syndrome
Moya Moya
Additional relevant MeSH terms:
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Moyamoya Disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases