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CompletedNCT02837354CAAUpdated Jul 19, 2016

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

An observational study in CADASIL, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2016-07-19.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • CADASIL

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Keywords

  • Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy
03

In context

CADASIL

33 studies on the registry are indexed under CADASIL; 18 are open to participants now.

This study's enrollment of 60 is below the median of 168 across 22 observational studies indexed under CADASIL.

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Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 346 studies on the registry; 51 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • No conditions
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention
06

What researchers measure

Primary outcomes

  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

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

    Time frame: Day 1

07

Study locations

1 site
  • Groupe Hospitalier Paris Saint Joseph
    Paris, Ile-de-France 75014, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Nov 2015 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2016
First posted
Jul 19, 2016
Start
Jun 2014
Primary completionActual
Nov 2015
CompletionActual
Jul 2016
Last update
Jul 19, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02837354
Lead sponsor
Fondation Hôpital Saint-Joseph
Responsible party
Sponsor
First posted
Jul 19, 2016
Start date
Jun 2014
Primary completion
Nov 2015
Completion
Jul 2016
Last update
Jul 19, 2016

Study contacts

JOIN-LAMBERT Claire, MD
principal investigator · Groupe Hospitalier Paris Saint-Joseph (FRANCE)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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