Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients

NCT05760326 | Unknown

• 1 other identifier: 5153
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND AND RATIONALE OF THE STUDY The analysis of the composition of the clot constitutes a promising tool for investigating the possible pathogenetic mechanisms underlying ischemic stroke. This analysis was made possible thanks to the numerous mechanical thrombectomy operations which have now become routine. Several studies have attempted to explore the possible relationship between the primary site of thrombus formation and clot composition, reporting that cardioembolic stroke may have a higher percentage of platelet-rich areas than noncardioembolic thrombosis. However, the data are conflicting and do not seem to support an association between clot histology and etiology. Furthermore, thrombus composition appears to influence thrombolysis and the efficacy of thrombectomy. For example, fibrin-rich thrombi appear to reduce the effectiveness of thrombolytic treatment and require more steps with mechanical thrombectomy treatment. Primary ENDPOINT: Evaluate how clot composition relates to stroke etiology according to the TOAST classification. Secondary ENDPOINT:

• relationship between different clot components and the degree of thrombectomy recanalization as defined by treatment modified cerebral ischemia score (mTICI).
• relationship between the different components of the clot and the number of steps required to achieve recanalization.
• relationship between the different clot components and outcome indicators (NIHSS score and mRS score). TARGET POPULATION Patients with ischemic stroke with occlusion of large intracranial vessels will be included in the study if deemed suitable for mechanical thrombectomy therapy in accordance with national and international guidelines. INCLUSION CRITERIA
• age \> 18 years;
• Patients diagnosed with large vessel occlusion stroke in the emergency room CT Angio-study, undergoing mechanical thrombectomy procedure.
• Recovered thrombus available for analysis EXCLUSION CRITERIA ● Lack of written informed consent. MATERIALS AND METHODS The clot will be portioned. Part of the sample will be fixed in a 10% formalin solution (3.7% formaldehyde), part will be frozen in liquid nitrogen. Within 24-48 hours of fixation, formalin-fixed thrombi will be dehydrated by increasing the concentration of ethanol (70%, -80%, -95%, 100%) and paraffin-embedded allowing good preservation of tissue morphology and easy long-term storage. The included samples will be sectioned along the major axis of the thrombus, in slices with a thickness between 4 and 5 µm. Base staining will be used to visualize RBC, PLT and fibrin.
• Hematoxylin and Eosin (H\&E) will allow visualization of general thrombus structures and identification of aggregates of fibrin/platelets (colored pink), red blood cells (red), and nucleated cells (dark blue).
• Martius Scarlet Blue (MSB), selectively stains fibrin (dark pink/red), red blood cells (yellow) and collagen (blue
• Mallory-Azan for collagen and phosphotungstic acid hematoxylin for fibrin.
• immunohistochemistry to detect the presence of
• Platelets (CD42-Gp-Ib+, CD41a-Gp-IIb/IIIa+, CD61-GpIIIa),
• white blood cells (CD45+, common leukocyte antigen), or monocytes/macrophages (CD14+, CD1a+, CD68+),
• T lymphocytes (CD3+, CD8/CD4+), or natural killers (CD16+, CD56+), or mobile premature endothelial cells and blood progenitors (CD34+), or neutrophils (CD45+, CD16+), or fibrinogen or von Willebrand factor.

Conditions

Stroke, Acute; Atherosclerosis; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Clot - TOAST correlation

  • To evaluate the association between thrombus composition, studied through histological and immunohistochemical coloration, and stroke etiology according to the TOAST classification. In particular, TOAST voices for etiological category will be dichotomize between "cardioembolic" and "not cardioembolic" (the latter including "large vessel occlusion", "other determined etiologies" and "other undetermined etiologies").

  1 year

Eligibility Criteria

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

Study Population

Patients hospitalized in the - Catholic University of the Sacred Heart, Policlinico Gemelli - Catholic University - Rome, with a stroke due to LVO treated with mechanical thrombectomy will be presented the study. Patient will be enrolled upon their presentation to the emergency department. The usual clinical practice will be followed. Considering the emergency setting and the impossibility for most patients to provide a valid and informed consent before e immediately after the procedures, retrieved thrombi will be collected but not analyze. An informed consent to the study will be collect in the following day. Should the patient refuse the participation, the thrombus will be discarded and the patient will be considered as a drop out from the study. Investigators plan to include 30 patients with acute ischemic stroke due to LVO treated with mechanical thrombectomy.

You may qualify if:

• age \> 18 years;
• Patients with a diagnosis of large vessel occlusion stroke at the Angio-CT study performed in the ER, undergoing a mechanical thrombectomy procedure.
• Thrombus retrieved available for analysis

You may not qualify if:

• Deny informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Stroke; Atherosclerosis; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Giovanni Frisullo, MD

CONTACT

3476612284; giovanni.frisullo@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 8, 2023
• Study Start: September 2, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-02

Locations

IT (1)