Biomarkers for the Diagnosis of Transient Ischemic Attack

NCT02799511 | Completed DMC

• 1 other identifier: 2014-A00346-41
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Disorders; Ischemic Attack, Transient

Keywords

biological markers

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 72h after TAI and 90 days after TAI

Study Arms (1)

protein expression

OTHER

Biological: protein expression

Interventions

protein expression BIOLOGICAL

Differential protein expression between the period of acute cerebral ischemia and the control period

protein expression

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Location

MeSH Terms

Conditions

Cerebrovascular Disorders; Ischemic Attack, Transient

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 15, 2016
• Study Start: March 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 5, 2021

Record last verified: 2019-12

Locations

FR (1)