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Biomarkers for the Diagnosis of Transient Ischemic Attack (MAESTRO)

Primary Purpose

Cerebrovascular Disorders, Ischemic Attack, Transient

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
protein expression
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebrovascular Disorders focused on measuring biological markers

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • TIA lasting 18h
  • NIHSS < 0
  • MRI diffusion hypersignal less than 5 ml
  • follow up during 3 month
  • written informed consent prior to any study procedures

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • major comorbidity (cancer, chronic infection)
  • recent trauma (less than 30 days) (cranial or extracranial)
  • Surgical or endovascular recent surgery(within 30 days).
  • Any old brain injury
  • Any acute pathology likely to induce inflammation, hemostasis disorders ...
  • Contraindications to MRI: Patients with a pacemaker, an implanted material activated by an electrical, magnetic or mechanical carriers hemostatic clips intracerebral aneurysms or carotid arteries, bearing orthopedic implants, claustrophobic ...
  • Patient under guardianship

Sites / Locations

  • Caen University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

protein expression

Arm Description

Outcomes

Primary Outcome Measures

change in proteomic analysis from MPs or from plasma.
Identify one or more markers of transient ischemic attack by a proteomic analysis from MPs or from plasma.

Secondary Outcome Measures

Full Information

First Posted
May 27, 2016
Last Updated
August 30, 2021
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02799511
Brief Title
Biomarkers for the Diagnosis of Transient Ischemic Attack
Acronym
MAESTRO
Official Title
Biomarkers for the Diagnosis of Transient Ischemic Attack
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A transient ischemic attack (TIA) should be considered an emergency prevention opportunity in order to avoid recurrence as cerebral infarction (CI) serious (fatal or disabling). Indeed, about 20% of patients who have IC had in previous days or weeks, a TIA, which can be defined as a brief episode of cerebral dysfunction (or eye) do not result in permanent brain damage and thus no sequelae. Moreover, about 20% of ischemic events observed in practice are AIT. Despite the progress achieved in the treatment in the acute phase of an IC, prevention remains the most effective way to fight against this disease. This prevention can be put in place before the occurrence of a first IC, or after a first IC, especially when minor as a TIA. However, the diagnosis of TIA remains particularly difficult and it is necessary now to identify new tools for the diagnosis of transient ischemic attack. Our study focused on the identification of one or more molecules (called biological markers or biomarkers) present in the bloodstream of patients, which will serve to facilitate the differential diagnosis of patients with TIA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders, Ischemic Attack, Transient
Keywords
biological markers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
protein expression
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
protein expression
Intervention Description
Differential protein expression between the period of acute cerebral ischemia and the control period
Primary Outcome Measure Information:
Title
change in proteomic analysis from MPs or from plasma.
Description
Identify one or more markers of transient ischemic attack by a proteomic analysis from MPs or from plasma.
Time Frame
baseline and 72h after TAI and 90 days after TAI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: TIA lasting 18h NIHSS < 0 MRI diffusion hypersignal less than 5 ml follow up during 3 month written informed consent prior to any study procedures Exclusion Criteria: Pregnant or breastfeeding women major comorbidity (cancer, chronic infection) recent trauma (less than 30 days) (cranial or extracranial) Surgical or endovascular recent surgery(within 30 days). Any old brain injury Any acute pathology likely to induce inflammation, hemostasis disorders ... Contraindications to MRI: Patients with a pacemaker, an implanted material activated by an electrical, magnetic or mechanical carriers hemostatic clips intracerebral aneurysms or carotid arteries, bearing orthopedic implants, claustrophobic ... Patient under guardianship
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Biomarkers for the Diagnosis of Transient Ischemic Attack

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