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The Silent Cortical Infarcts in the Cerebral Amyloid Angiopathy: Is There a Link With Subarachnoid Hemorrhage? (CAA)

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ClinicalTrials.gov Identifier: NCT02837354
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:
The Cerebral Amyloid angiopathy (CAA) is the leading cause of cortical hemorrhage after 65 years. The presence of cerebral infarction is also reported anatomically in the AAC. MRI studies of these infarcts are rare. They are described as punctate, cortical silent. Frequency and pathophysiology is poorly understood. The investigators put the question of a link with hemorrhagic lesions of the AAC.

Condition or disease Intervention/treatment
CADASIL Other: No intervention

Detailed Description:

Main objective / secondary

The objectives are:

  • To assess frequency of cortical infarcts in the cohort of patients recruited consecutively likely AAFC GHPSJ since 2007
  • To assess the link between the presence of myocardial infarction and the clinical characteristics of patients and
  • To study the relationship between topography and the brain hemorrhage one hand, meningeal hemorrhage other.

Inclusion / exclusion Any patient who was diagnosed as carrying a probable AAC according to the Boston criteria and has had a brain MRI with the following sequences: classic or enhanced diffusion (or DTI B2000), T1, T2 FLAIR, T2EG (T2 * or SWAN)

Methodology This is a non-interventional study single center, including AAC patients hospitalized in the Hospital Group Paris Saint-Joseph from May 2007 to May 2014.

Clinical patient characteristics were collected from their medical records. Patients are aware of the potential use of their data for medical research by information contained in the handbook of the institution.

Brain MRI will be proofread by a neurologist and a neuroradiologist to clarify:

  • the number and location of myocardial puncture
  • the number and location of macro-bleeding
  • the number of microbleeds (micro-bleeding)
  • the presence and location of subarachnoid hemorrhage and / or hemosiderosis
  • the location of the puncture infarction compared to macro-hemorrhage and subarachnoid hemorrhage / hemosiderosis: ipsilateral <5cm, ipsilateral> 5cm, another location The clinical data and MRI will be entered on a file, with data anonymisation. Statistical analysis will be done by a neurologist service.

Number of topics:

  • It is estimated that enrollment of patients with AAC by the UNV GHPSJ is approximately 10 patients per year. The number of screened patients during the study period should be about 70.
  • Taking into account those whose MRI will be judged of insufficient quality (excluded), the number of patients included in the analysis should be around 50.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Silent Cortical Infarcts in the Cerebral Amyloid Angiopathy: Is There a Link With Subarachnoid Hemorrhage?
Study Start Date : June 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : July 2016





Primary Outcome Measures :
  1. the number and location of myocardial puncture [ Time Frame: Day 1 ]
  2. the number and location of macro-bleeding [ Time Frame: Day 1 ]
  3. the number of microbleeds (micro-bleeding) [ Time Frame: Day 1 ]
  4. the presence and location of subarachnoid hemorrhage and / or hemosiderosis [ Time Frame: Day 1 ]
  5. the location of the puncture infarction [ Time Frame: Day 1 ]
    the location of the puncture infarction compared to macro-hemorrhage and subarachnoid hemorrhage / hemosiderosis: ipsilateral <5cm, ipsilateral> 5cm, another location



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient who was diagnosed as carrying a probable AAC according to the Boston criteria and has had a brain MRI with the following sequences: classic or enhanced diffusion
Criteria

Inclusion Criteria:

  • Any patient who was diagnosed as carrying a probable AAC according to the Boston criteria and has had a brain MRI with the following sequences: classic or enhanced diffusion

Exclusion Criteria:

  • No conditions

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): NCT02837354


Locations
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France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: JOIN-LAMBERT Claire, MD Groupe Hospitalier Paris Saint-Joseph (FRANCE)

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02837354     History of Changes
Other Study ID Numbers: CAA
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Infarction
Cerebral Amyloid Angiopathy
Cerebral Amyloid Angiopathy, Familial
CADASIL
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Necrosis
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Cerebral Small Vessel Diseases
Amyloidosis, Familial
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Dementia, Vascular
Dementia