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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

Groupe Hospitalier Paris Saint Joseph

Paris, Ile-de-France, France, 75014

Sponsors and Collaborators

Groupe Hospitalier Paris Saint Joseph

Investigators

• Principal Investigator: JOIN-LAMBERT Claire, MD; Groupe Hospitalier Paris Saint-Joseph (FRANCE)

More Information

• Responsible Party: Groupe Hospitalier Paris Saint Joseph
• ClinicalTrials.gov Identifier: NCT02837354
• Other Study ID Numbers: CAA
• First Posted: July 19, 2016
• 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:

Subarachnoid Hemorrhage; Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial; CADASIL; Hemorrhage; Infarction; 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