RNA Sequencing Analysis in Large Vessel Occlusion Stroke DATA Bank
RNASA-LVOSB
2 other identifiers
interventional
370
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 26, 2018
CompletedFirst Posted
Study publicly available on registry
April 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedApril 6, 2018
March 1, 2018
3.6 years
March 26, 2018
March 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Mrs
Modified ranking scale
30 days
Secondary Outcomes (1)
Sensitivity & Specificity
4 years
Study Arms (2)
group A
SHAM COMPARATORinclude clots which have been extracted by mechanical thrombectomy and with definite stroke etiology and submitted to the RNA analysis in blinded coded label .
group B
EXPERIMENTALinclude all clots which have been extracted by mechanical thrombectomy and with unknown stroke etiology and submitted to RNA analysis in cryptogenic label.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Society of Minimally Invasive Neurological Therapeutic Procedureslead
- Pakistani Society of Neuroradiologycollaborator
- Middle east North Africa Stroke & interventional Neurotherapies Organizationcollaborator
- Egyptian Stroke Societycollaborator
- African Academy of neurologycollaborator
- Egyptian Society for Progenitor Cell Researchcollaborator
Study Sites (1)
Alexandria University , School of medicine , Neurology Department, Neurovascular Unit
Alexandria, 22121, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2018
First Posted
April 6, 2018
Study Start
January 1, 2018
Primary Completion
July 31, 2021
Study Completion
January 31, 2022
Last Updated
April 6, 2018
Record last verified: 2018-03