NCT02828488

Brief Summary

Fragility, geriatric concept recent identification is defined by simple physical indicators. The literature suggests that it is related to the risk of hospitalization, falls, institutionalization and death. Some studies have shown a link with heart disease, including heart failure. The link with the TIA (transient ischemic attack) has however never been studied. A fortiori, the impact of the fragility of the risk of recurrent stroke after TIA is unknown. Several questions need to be asked: Among older patients hospitalized for TIA, what proportion of those completing the criteria of frailty? In this same population, is there a correlation between fragility and scores ABCD2 score itself predictive of the risk of subsequent ischemic stroke? In other words, fragile subjects who have a TIA Have a higher risk of ischemic stroke (which could cause a strengthening of prevention measures)?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 6, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

3.9 years

First QC Date

July 7, 2016

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fried Score for fragility

    Day 1

Secondary Outcomes (1)

  • ABCD Score

    Day 1

Interventions

It is a descriptive study. No intervention

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All TIA patients over 70 years hospitalized ICU neurovascular at GHPSJ (Groupe Hospitalier Paris Saint Joseph):

You may qualify if:

  • The TIA is defined pragmatically: any sudden deficit with blood systematization ≤ 1 hour. Among these "TIA", we know that a subgroup may possibly have an MRI with diffusion lesion, indicating a recent ischemic stroke. This subgroup of transient accident is recognized as being at higher risk of recurrence. This criterion will be taken into account in the data analysis.

You may not qualify if:

  • history of stroke with Rankin score of ≥ 2.
  • Dementia
  • Severe depression
  • evolutionary Cancer
  • Heart Failure

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

IschemiaIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • BRUANDET Marie, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 11, 2016

Study Start

August 6, 2015

Primary Completion

June 30, 2019

Study Completion

December 31, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations