Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02837354
Other study ID # CAA
Secondary ID
Status Completed
Phase N/A
First received July 13, 2016
Last updated July 18, 2016
Start date June 2014
Est. completion date July 2016

Study information

Verified date July 2016
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
No intervention


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 the number and location of myocardial puncture Day 1 No
Primary the number and location of macro-bleeding Day 1 No
Primary the number of microbleeds (micro-bleeding) Day 1 No
Primary the presence and location of subarachnoid hemorrhage and / or hemosiderosis Day 1 No
Primary the location of the puncture infarction the location of the puncture infarction compared to macro-hemorrhage and subarachnoid hemorrhage / hemosiderosis: ipsilateral <5cm, ipsilateral> 5cm, another location Day 1 No
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03724136 - Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study N/A
Recruiting NCT05755997 - CERebrolysin In CADASIL Phase 2
Recruiting NCT06148051 - AusCADASIL: An Australian Cohort of CADASIL
Recruiting NCT04310098 - CADASIL Registry Study
Completed NCT01114815 - Research Study on Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL) N/A
Recruiting NCT05677880 - Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL) Study
Recruiting NCT02795052 - Neurologic Stem Cell Treatment Study N/A
Recruiting NCT01361763 - Safety Study of Dabigatran in CADASIL Phase 2
Completed NCT02071784 - Imaging Study of Neurovascular Coupling in Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)
Completed NCT06072118 - Adrenomedullin for CADASIL Phase 2
Active, not recruiting NCT02699190 - LeukoSEQ: Whole Genome Sequencing as a First-Line Diagnostic Tool for Leukodystrophies
Recruiting NCT05473637 - Taiwan Associated Genetic and Nongenetic Small Vessel Disease
Enrolling by invitation NCT02032225 - Generation of a Cellular Model of CADASIL From Skin Fibroblasts N/A
Recruiting NCT03047369 - The Myelin Disorders Biorepository Project
Active, not recruiting NCT04658823 - Efficacy and Safety of Tocotrienols in CADASIL Phase 2
Withdrawn NCT04334408 - Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL Phase 2
Recruiting NCT05734378 - Prognosis of Cerebral Small Vessel Disease
Recruiting NCT05491980 - Florida Cerebrovascular Disease Biorepository and Genomics Center
Recruiting NCT04036084 - Development of New Biomarkers With Magnetic Resonance Imaging for Longitudinal Studies in CADASIL Angiopathy
Completed NCT01865604 - Impact of tDCS on Cerebral Autoregulation N/A