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

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Completed
CT.gov ID
NCT02837354
Collaborator
(none)
60
1
25
2.4

Study Details

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 Phase
  • 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 :
Jun 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Jul 1, 2016

Outcome Measures

Primary Outcome Measures

  1. the number and location of myocardial puncture [Day 1]

  2. the number and location of macro-bleeding [Day 1]

  3. the number of microbleeds (micro-bleeding) [Day 1]

  4. the presence and location of subarachnoid hemorrhage and / or hemosiderosis [Day 1]

  5. the location of the puncture infarction [Day 1]

    the location of the puncture infarction compared to macro-hemorrhage and subarachnoid hemorrhage / hemosiderosis: ipsilateral <5cm, ipsilateral> 5cm, another location

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 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)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT02837354
Other Study ID Numbers:
  • CAA
First Posted:
Jul 19, 2016
Last Update Posted:
Jul 19, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Groupe Hospitalier Paris Saint Joseph
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2016