Biomarkers for the Diagnosis of Transient Ischemic Attack (MAESTRO)

August 30, 2021 updated by: University Hospital, Caen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

  • France
      • Caen, France, 14033
        • CAEN University Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: protein expression
Biological: protein expression
Differential protein expression between the period of acute cerebral ischemia and the control period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in proteomic analysis from MPs or from plasma.
Time Frame: baseline and 72h after TAI and 90 days after TAI
Identify one or more markers of transient ischemic attack by a proteomic analysis from MPs or from plasma.
baseline and 72h after TAI and 90 days after TAI

Collaborators and Investigators

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

Sponsor

University Hospital, Caen

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

March 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00346-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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