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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03262246
Other study ID # ISAAC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2, 2016
Est. completion date December 31, 2018

Study information

Verified date August 2018
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid peptids in the walls of the arteries of young and average calibre of the brain and the leptomeninx. The incidence of the AAC increases strongly with the age and represents a major cause of spontaneous brain haemorrhage to people over 60. The main demonstration is the lobar brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings leading to cognitive decline.

Anatomical studies reported the presence of cortical infarcts in patients having amyloïd deposits suggesting an association between asymptomatic cortical cerebral infarcts and AAC.

However prevalence and meaning of these infarcts in patients having an AAC remain badly known because of studies on low number of patients and the rarity of radiological analyses of these infarcts .A better knowledge of these asymptomatic cortical infarcts would allow to dread better cognitive disorders(confusions) presented by these patients, and to develop preventive strategies.

Besides, the risk factors of severity of the AAC are little studied.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date December 31, 2018
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

- age>55

- hospitalized in CAEN hospital and Paris St Joseph Hospital between 1st january 2011 and 31 december 2015 for cerebral haemorrhage with MRI images diagnosing cerebral amyloid angiopathy.

Exclusion Criteria:

- Insufficient MRI images quality without FLAI sequence, T2 GRE

- disease with same radiologic and clinical signs that cerebral amyloid angiopathy.

Study Design


Intervention

Other:
medical report consultation
investigators consult medical report concerning patient identified for cerebral amyloid angiopathy

Locations

Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of patient with cerebral infarction and associated factors in a cohort of cerebral amyloid angiopathy patients 1day
See also
  Status Clinical Trial Phase
Completed NCT05475158 - Comparison of OCTA Factors in Patients With or Without Amyloid Pathology: A Prospective Study