Using biomarkers to identify acute stroke patients with unknown onset

Biological Dating of Cerebral Ischemia With Glutathion S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1) to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis

This study is testing two blood markers to see if they can help doctors quickly identify stroke patients who need treatment within the first few hours of their symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 930 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Central Hospital, Nancy, France (other)
• Locations: 5 sites (Bar-le-Duc and 4 other locations)
• Trial ID: NCT03364296 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of two biomarkers, Glutathion S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1), in diagnosing cerebral infarction in patients who exhibit neurological deficiencies. It focuses on patients who have experienced symptoms consistent with a stroke within the last 24 hours, particularly those with a symptom onset of less than 4.5 hours. Blood samples will be collected to analyze these biomarkers, and MRI scans will be performed shortly after blood collection to confirm the diagnosis. The goal is to improve the identification of stroke patients who are within the therapeutic window for thrombolysis treatment.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old with stroke symptoms and a National Institute of Health Stroke Score of 3 or higher.

Not a fit: Patients with stroke symptoms that have been present for more than 24 hours or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to faster and more accurate diagnosis of acute strokes, allowing timely treatment for patients.

How similar studies have performed: While the use of biomarkers in stroke diagnosis is an emerging field, this specific approach has not been extensively tested in prior studies, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

* Patients over 18 years old
* Patients with symptoms consistent with stroke and a National Institute of Health Stroke Score ≥3 at the inclusion time
* Time symptom onset ≤ 24 hours at inclusion:

  * For patients with time of symptom onset is \<4.5h at inclusion, the time of symptom onset has to be precisely known, with a margin of error not exceeding 30 minutes (through patient or witness interview)
  * For patients with time of symptom onset is \>4.5h at inclusion, knowledge of precise time of symptom onset is not required. For these patients, to ensure onset-to-inclusion time is between 4.5 and 24 hours at inclusion:
* last time patient presented no deficit must be less than 24 hours,
* symptoms must have been first recognized more than 4.5 hours before blood draw.
* Possibility to perform MRI within the 30 minutes following blood collection
* Person affiliated to or beneficiary of a social security plan

Exclusion Criteria:

* Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the French Public Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of public guardianship) ; Adult person incapable of giving consent and not under legal protection.
* Persons deprived of liberty for judicial or administrative decision.
* Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code.
* Known cancer in progression.
* Known cirrhosis.
* Myocardial Infarctions, stroke, Subarachnoid hemorrhage or intracranial injury within 3 months prior to enrolment.

Where this trial is running

Bar-le-Duc and 4 other locations

• Centre Hospitalier de Bar-Le-Duc — Bar-le-Duc, France (RECRUITING)
• Hôpital Central — Nancy, France (RECRUITING)
• Fondation Adolphe de Rothschild — Paris, France (RECRUITING)
• Centre Hospitalier de Troyes — Troyes, France (RECRUITING)
• Centre Hospitalier de Verdun — Verdun, France (RECRUITING)

Study contacts

• Study coordinator: Sébastien RICHARD, MD

Conditions: Stroke, Acute, Acute stroke, Biomarkers