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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02828488
Recruitment Status : Active, not recruiting
First Posted : July 11, 2016
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

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)?


Condition or disease Intervention/treatment
Vascular Stoke Ischemic Transient Ischemic Attack Other: No intervention

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.

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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of the Impact of the Fragility of the Over 70 Years of TIA (Transient Ischemic Attack) Prognosis
Actual Study Start Date : August 6, 2015
Actual Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention
    It is a descriptive study. No intervention


Primary Outcome Measures :
  1. Fried Score for fragility [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. ABCD Score [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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):
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828488


Locations
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France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: BRUANDET Marie, MD Groupe Hospitalier Paris Saint Joseph
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02828488    
Other Study ID Numbers: AIT70
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Ischemia
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases