NCT02819167

Brief Summary

Ischemic strokes are one of the leading causes of handicap and death in elderly people in France. Cognitive reserve (CR) is an active model, defined as a function of lifetime intellectual activities and other environmental factors that explain differential susceptibility to functional impairment in the presence of pathology or other neurological insult. CR is estimated using variables for cognitive activity: years of education, professional status, socioeconomic status… Furthermore, brain reverse (BR) is a passive and quantitative model that depend on brain size and other quantitative aspects of the brain that explain differential susceptibility to functional impairment in the presence of pathology. Firstly, volume and localization of ischemic strokes have a great impact on CR and BR due to brain injury. On the other hand, CR influences the severity and the expression of cognitive diseases. The investigators realize a prospective study in order to assess the impact of CR and BR on cognitive prognosis after a right middle cerebral artery ischemic stroke in elderly patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

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

May 26, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

June 28, 2016

Last Update Submit

November 16, 2017

Conditions

Keywords

ischemic strokebrain reservecognitive reservecognitive prognosis

Outcome Measures

Primary Outcomes (1)

  • evaluation of cognitive prognosis

    measure will be performed with the Mattis dementia rating scale

    one year post Ischemic stroke

Secondary Outcomes (5)

  • Volume of leucoencephalopathy

    one year post Ischemic stroke

  • volume of hippocampic

    one year post Ischemic stroke

  • brain injury

    one year post Ischemic stroke

  • volume of ischemic stroke

    one year post Ischemic stroke

  • evaluation of cognitive reserve

    one year post Ischemic stroke

Study Arms (1)

neurologic and neuropsychological evaluation

OTHER
Other: neurologic and neuropsychological evaluation

Interventions

cognitive prognosis, cognitive reserve, brain volume will be studied on patients with scale, questionnaire, magnetic resonance imaging

neurologic and neuropsychological evaluation

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥70 years old
  • right middle cerebral artery ischemic stroke
  • hospitalized in neurovascular unit of Pierre Wertheimer hospital between January 2015 to January 2016

You may not qualify if:

  • Contraindication for MRI
  • Hemorrhagic stroke
  • Aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital des Charpennes

Lyon, France

Location

MeSH Terms

Conditions

Brain IschemiaIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStroke

Study Officials

  • Pierre Krolak Salmon, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

June 30, 2016

Study Start

May 26, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations