NCT03490552

RNA Sequencing Analysis in Large Vessel Occlusion Stroke DATA Bank

RNA Sequencing Analysis in Large Vessel Occlusion Stroke DATA Bank (RNASA-LVOSB), the Futuristic Finger Print Recognition of Stroke Source

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: Society of Minimally Invasive Neurological Therapeutic Procedures · Network
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Introduction: the source of embolic stroke , in thrombotic embolism , is of unknown origin in 30-40% of cases. Fortunately , Mechanical thrombectomy provide a direct method to retrieve the stroke-incriminated clots from stroke patients for possibility of exo-autopsy analysis.

Detailed description

Introduction: the source of embolic stroke , in thrombotic embolism , is of unknown origin in 30-40% of cases. Fortunately , Mechanical thrombectomy provide a direct method to retrieve the stroke-incriminated clots from stroke patients for possibility of exo-autopsy analysis. Aim of the study : collecting stroke-incriminated clots from definite known etiological sources, could build a matchable markers database (MMD) to identify the source of cryptogenic embolism in the near-future. Identification of that markers is done by novel RNA sequencing technology to identify the clot composition in direct way. Methodology: This is a prospective REB-approved study of acute LVO ischemic stroke in patients receiving mechanical thrombectomy at a multiple centers . Immediately after thrombi will be retrieved by mechanical thrombectomy, they will be placed in RNA stabilization and storage solution (RNAlater). Each sample will be extracted for total RNA by the one approved regional university's Human Genomics lab using a standard protocol. NanoDrop Microvolume Spectrophotometers and Fluorometer will be used for RNA quantification. Thrombi weight will be recorded among other patient data , risk factors , procedural data, usage of adjunctive drugs and macroscopic morphology of each clot . Pearson correlation was used for correlation analysis. all clots will be handled in double blinded control manner ; where clots analysis will be divided into 2 groups where Group A : include clots with definite stroke etiology and submitted to the RNA analysis in blinded coded label . Group B: include all clots with unknown stroke etiology and submitted to RNA analysis in cryptogenic label . the trial will be conducted over 4 years period from 2018 to 2022, with expected sample size of 350 cases with 7 : 3 ratio of enrollment in both groups ( a, b). all analysis will be re-audited in central genome analysis lab of Alexandria University .

Conditions

• Stroke, Acute
• Thrombosis

Interventions

Type	Name	Description
PROCEDURE	mechanical thrombectomy	Mechanical thrombectomy whatever it type ( SRT , ASPT or Mixed )will be used to extract the thrombi from stroke causing occlusion to be preserved biologically for genomic lab. transfer to be processed by RNA sequencing analysis technique for identifying markers for its composition pointing to its source.

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-07-31
• Completion: 2022-01-31
• First posted: 2018-04-06
• Last updated: 2018-04-06

Locations

1 site across 1 country: Egypt