- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02828488
Analysis of the Impact of the Fragility of the Over 70 Years of TIAprognosis (AIT70)
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ile-de-France
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Paris, Ile-de-France, France, 75014
- Groupe hospitalier Paris saint Joseph
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: BRUANDET Marie, MD, Groupe hospitalier Paris saint Joseph
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIT70
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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