NCT02837354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

July 13, 2016

Last Update Submit

July 18, 2016

Conditions

Keywords

Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy

Outcome Measures

Primary Outcomes (5)

  • the number and location of myocardial puncture

    Day 1

  • the number and location of macro-bleeding

    Day 1

  • the number of microbleeds (micro-bleeding)

    Day 1

  • the presence and location of subarachnoid hemorrhage and / or hemosiderosis

    Day 1

  • 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

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • No conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

CADASIL

Condition Hierarchy (Ancestors)

Cerebral InfarctionBrain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Small Vessel DiseasesDementia, VascularCerebral Arterial DiseasesIntracranial Arterial DiseasesStrokeDementiaVascular DiseasesCardiovascular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • JOIN-LAMBERT Claire, MD

    Groupe Hospitalier Paris Saint-Joseph (FRANCE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 19, 2016

Study Start

June 1, 2014

Primary Completion

November 1, 2015

Study Completion

July 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations