Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490552
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
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
Information provided by (Responsible Party):
Society of Minimally Invasive Neurological Therapeutic Procedures

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Thrombosis Procedure: mechanical thrombectomy Not Applicable

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 .

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A double blind, randomized, controlled investigational study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: RNA Sequencing Analysis in Large Vessel Occlusion Stroke DATA Bank (RNASA-LVOSB), the Futuristic Finger Print Recognition of Stroke Source
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: group A
include clots which have been extracted by mechanical thrombectomy and with definite stroke etiology and submitted to the RNA analysis in blinded coded label .
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.
Other Name: RNA Sequencing Analysis

Experimental: group B
include all clots which have been extracted by mechanical thrombectomy and with unknown stroke etiology and submitted to RNA analysis in cryptogenic label.
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.
Other Name: RNA Sequencing Analysis




Primary Outcome Measures :
  1. Mrs [ Time Frame: 30 days ]
    Modified ranking scale


Secondary Outcome Measures :
  1. Sensitivity & Specificity [ Time Frame: 4 years ]
    match sensitivity more than 90 % and Specificity more than 80%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Informed consent as documented by signature
  2. Age ≥ 18 to < 86 years
  3. Clinical signs consistent with an acute ischemic stroke
  4. Neurological deficit with a NIHSS of ≥ 8 and < 30
  5. Patient is eligible for intravenous thrombolysis
  6. Patient is eligible for endovascular treatment
  7. 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)
  8. 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
  9. 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:

  1. Acute intracranial hemorrhage
  2. Any contraindication for IV t-PA
  3. Pre-treatment with IV t-PA
  4. In-hospital stroke
  5. Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential.
  6. Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals, or their alloys
  7. Known current participation in a clinical trial (investigational drug or medical device)
  8. 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
  9. Severe comorbid condition with life expectancy less than 90 days at baseline
  10. Known advanced dementia or significant pre-stroke disability (mRS score of ≥2)
  11. Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
  12. Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
  13. 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).
  14. 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
  15. Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
  16. Radiological confirmed evidence of cerebral vasculitis
  17. CTA or MRA evidence of carotid artery dissection
  18. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490552


Contacts
Layout table for location contacts
Contact: ossama mansour, MD, PhD 00201223926932 yassinossama@yahoo.com
Contact: Foad Abd-allah, MD,PhD neurointervention2005@yahoo.com

Locations
Layout table for location information
Egypt
Alexandria University , School of medicine , Neurology Department, Neurovascular Unit Recruiting
Alexandria, Egypt, 22121
Contact: ossama Mansour, MD,PhD,FNR    01223926932    yassinossama@yahoo.com   
Principal Investigator: Ossmam Mansour, MD,PhD,FNR         
Sub-Investigator: abdelrahman mostafa, Msc         
Sub-Investigator: Mohamed Anwer, MS         
Principal Investigator: Foad Abd-allah, MD,PhD         
Principal Investigator: Umair Rashid, MD         
Principal Investigator: Anchalee Churojana, MD         
Principal Investigator: Mohamed Ghorbani         
Principal Investigator: Farid eladham, MD         
Principal Investigator: haytham hussein, MD         
Sponsors and Collaborators
Society of Minimally Invasive Neurological Therapeutic Procedures
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

Layout table for additonal information
Responsible Party: Society of Minimally Invasive Neurological Therapeutic Procedures
ClinicalTrials.gov Identifier: NCT03490552    
Other Study ID Numbers: MENA-SINO-T001
MENASINO-001 ( Other Identifier: MENA-SINO )
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis