Analysis of the Impact of the Fragility of the Over 70 Years of TIAprognosis (AIT70)

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Analysis of the Impact of the Fragility of the Over 70 Years of TIA (Transient Ischemic Attack) Prognosis

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)?

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

Hypotheses :

  • Frailty is common among the elderly patient population who have a TIA. Compared to control groups of literature.
  • Patients with high fragility score ABCD2 also have a high score.
  • Patients with a high score of fragility also have a significant number of vascular risk factors (including atrial fibrillation)
  • Patients with a high score of fragility also have an average length of stay (ALOS) higher than the others. So underlying the question is: can we learn to better identify patients who are going to need a bigger structure their output at home.

objectives:

  • Assess the feasibility of placing a fragile test in acute phase of AIT in USINV.
  • To evaluate the frequency of frailty among the population of elderly patients who have a TIA.
  • Compare in AIT over 70 years those with fragile high score to those with low scores, especially for ABCD2 score, vascular risk factors and the DMS.
  • Statements parameters:

    o The fragility score:

  • Choice of fragility score: among the fragility of scores, the most used in international literature is the score of Linda Fried. Moreover, the stress of the study is related to the environment of the USINV (shortly, short DMS, often tired patients). It is therefore important to use this study for a test only, but quick handover. The score Fried also has the advantage (J Gerontol A Biol Sci Med Sci 2001, 56 (3): M146-56) The first 4 items are simple clinical evaluation. The 5th (grip test) will be performed with a device (single gauge measuring the fingers bending strength) loan from the geriatric ward.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe hospitalier Paris saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fried Score for fragility
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
ABCD Score
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: BRUANDET Marie, MD, Groupe hospitalier Paris saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2015

Primary Completion (Actual)

June 30, 2019

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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