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RNA Sequencing Analysis in Large Vessel Occlusion Stroke DATA Bank (RNASA-LVOSB)

Primary Purpose

Stroke, Acute, Thrombosis

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

mechanical thrombectomy

About this trial

This is an interventional diagnostic trial for Stroke, Acute

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Informed consent as documented by signature
Age ≥ 18 to < 86 years
Clinical signs consistent with an acute ischemic stroke
Neurological deficit with a NIHSS of ≥ 8 and < 30
Patient is eligible for intravenous thrombolysis
Patient is eligible for endovascular treatment
Randomization no later than 4 hours 15 minutes after stroke symptom onset and initiation of IV t-PA must be started within 4 hours 30 minutes of stroke symptoms onset (onset time is measured from the time when the subject was last seen well)
Occlusion (TICI 0-1) of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography, accessible for MT
Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) greater than or equal to 6 (≥6) based on baseline CT or MR imaging (MRI)

Exclusion Criteria:

Acute intracranial hemorrhage
Any contraindication for IV t-PA
Pre-treatment with IV t-PA
In-hospital stroke
Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential.
Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals, or their alloys
Known current participation in a clinical trial (investigational drug or medical device)
Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) or glomerular filtration rate (GFR) < 30 mL/min or requirement for hemodialysis or peritoneal dialysis
Severe comorbid condition with life expectancy less than 90 days at baseline
Known advanced dementia or significant pre-stroke disability (mRS score of ≥2)
Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the femoral access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after MT
Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
Radiological confirmed evidence of cerebral vasculitis
CTA or MRA evidence of carotid artery dissection
Evidence of additional distal intracranial vessel occlusion in another territory (i.e. A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRI or CTA/MRA

Sites / Locations

Alexandria University , School of medicine , Neurology Department, Neurovascular UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

group A

group B

Arm Description

include clots which have been extracted by mechanical thrombectomy and with definite stroke etiology and submitted to the RNA analysis in blinded coded label .

include all clots which have been extracted by mechanical thrombectomy and with unknown stroke etiology and submitted to RNA analysis in cryptogenic label.

Outcomes

Primary Outcome Measures

Mrs

Modified ranking scale

Secondary Outcome Measures

Sensitivity & Specificity

match sensitivity more than 90 % and Specificity more than 80%

Full Information

NCT ID

NCT03490552

First Posted

March 26, 2018

Last Updated

March 30, 2018

Sponsor

Society of Minimally Invasive Neurological Therapeutic Procedures

Collaborators

Pakistani Society of Neuroradiology, Middle east North Africa Stroke & interventional Neurotherapies Organization, Egyptian Stroke Society, African Academy of neurology, Egyptian Society for Progenitor Cell Research

1. Study Identification

Unique Protocol Identification Number

NCT03490552

Brief Title

RNA Sequencing Analysis in Large Vessel Occlusion Stroke DATA Bank

Acronym

RNASA-LVOSB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

July 31, 2021 (Anticipated)

Study Completion Date

January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Society of Minimally Invasive Neurological Therapeutic Procedures

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Acute, Thrombosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A double blind, randomized, controlled investigational study

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Sham Comparator

Arm Description

include clots which have been extracted by mechanical thrombectomy and with definite stroke etiology and submitted to the RNA analysis in blinded coded label .

Arm Title

group B

Arm Type

Experimental

Arm Description

include all clots which have been extracted by mechanical thrombectomy and with unknown stroke etiology and submitted to RNA analysis in cryptogenic label.

Intervention Type

Procedure

Intervention Name(s)

mechanical thrombectomy

Other Intervention Name(s)

RNA Sequencing Analysis

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mrs

Description

Modified ranking scale

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Sensitivity & Specificity

Description

match sensitivity more than 90 % and Specificity more than 80%

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent as documented by signature Age ≥ 18 to < 86 years Clinical signs consistent with an acute ischemic stroke Neurological deficit with a NIHSS of ≥ 8 and < 30 Patient is eligible for intravenous thrombolysis Patient is eligible for endovascular treatment Randomization no later than 4 hours 15 minutes after stroke symptom onset and initiation of IV t-PA must be started within 4 hours 30 minutes of stroke symptoms onset (onset time is measured from the time when the subject was last seen well) Occlusion (TICI 0-1) of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography, accessible for MT Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) greater than or equal to 6 (≥6) based on baseline CT or MR imaging (MRI) Exclusion Criteria: Acute intracranial hemorrhage Any contraindication for IV t-PA Pre-treatment with IV t-PA In-hospital stroke Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential. Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals, or their alloys Known current participation in a clinical trial (investigational drug or medical device) Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) or glomerular filtration rate (GFR) < 30 mL/min or requirement for hemodialysis or peritoneal dialysis Severe comorbid condition with life expectancy less than 90 days at baseline Known advanced dementia or significant pre-stroke disability (mRS score of ≥2) Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day). Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the femoral access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after MT Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma) Radiological confirmed evidence of cerebral vasculitis CTA or MRA evidence of carotid artery dissection Evidence of additional distal intracranial vessel occlusion in another territory (i.e. A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRI or CTA/MRA

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ossama mansour, MD, PhD

Phone

00201223926932

yassinossama@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Foad Abd-allah, MD,PhD

neurointervention2005@yahoo.com

Facility Information:

Facility Name

Alexandria University , School of medicine , Neurology Department, Neurovascular Unit

City

Alexandria

ZIP/Postal Code

22121

Country

Egypt

Individual Site Status

Recruiting

Facility Contact: