The Silent Cortical Infarcts in the Cerebral Amyloid Angiopathy: Is There a Link With Subarachnoid Hemorrhage? (CAA)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02837354|
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
|Condition or disease||Intervention/treatment|
|CADASIL||Other: No intervention|
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.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|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|
- the number and location of myocardial puncture [ Time Frame: Day 1 ]
- the number and location of macro-bleeding [ Time Frame: Day 1 ]
- the number of microbleeds (micro-bleeding) [ Time Frame: Day 1 ]
- the presence and location of subarachnoid hemorrhage and / or hemosiderosis [ Time Frame: Day 1 ]
- 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
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
|Groupe Hospitalier Paris Saint Joseph|
|Paris, Ile-de-France, France, 75014|
|Principal Investigator:||JOIN-LAMBERT Claire, MD||Groupe Hospitalier Paris Saint-Joseph (FRANCE)|