Stroke, AcuteRNASA-LVOSBNCT03490552
RNA Sequencing Analysis in Large Vessel Occlusion Stroke DATA Bank
A study testing mechanical thrombectomy in people with Stroke, Acute and Thrombosis, run by Society of Minimally Invasive Neurological Therapeutic Procedures at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Thrombosis
- What is being tested?
- mechanical thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Foad Abd-allah, MD,PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University , School of medicine , Neurology Department, Neurovascular Unit
Alexandria, 22121
ossama Mansour, MD,PhD,FNR, 01223926932, yassinossama@yahoo.com
Ossmam Mansour, MD,PhD,FNR
About this study
Official title: RNA Sequencing Analysis in Large Vessel Occlusion Stroke DATA Bank (RNASA-LVOSB), the Futuristic Finger Print Recognition of Stroke Source
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.
Read the 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
- Being tested
- mechanical thrombectomy
- Medical subject headings
- Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical thrombectomyProcedure or surgery
Also called RNA Sequencing Analysis
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.
| Study group | Role | What they receive |
|---|---|---|
| group A | Sham comparator | include clots which have been extracted by mechanical thrombectomy and with definite stroke etiology and submitted to the RNA analysis in blinded coded label . Receives: Procedure: mechanical thrombectomy |
| group B | Experimental | include all clots which have been extracted by mechanical thrombectomy and with unknown stroke etiology and submitted to RNA analysis in cryptogenic label. Receives: Procedure: mechanical thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mrs
Modified ranking scale
Measured: 30 days
Secondary outcomes (1)
Sensitivity & Specificity
match sensitivity more than 90 % and Specificity more than 80%
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Jan 2018
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double blind, randomized, controlled investigational study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Society of Minimally Invasive Neurological Therapeutic Procedures
- Sponsor type
- Research network
- Collaborators
- Pakistani Society of Neuroradiology, Middle East North Africa Stroke and Interventional Neurotherapies Organization, Egyptian Stroke Society, African Academy of neurology, Egyptian Society for Progenitor Cell Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490552
- Sponsor's protocol ID
- MENA-SINO-T001
- Other IDs
- MENASINO-001
- Acronym
- RNASA-LVOSB
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2018
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RNA Sequencing Analysis in Large Vessel Occlusion Stroke DATA Bank (RNASA-LVOSB), the Futuristic Finger Print Recognition of Stroke Source
- ClinicalTrials.gov ID
- NCT03490552
- Acronym / sponsor ID
- RNASA-LVOSB / MENA-SINO-T001
- Conditions
- Stroke, Acute, Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Society of Minimally Invasive Neurological Therapeutic ProceduresResearch network
- Collaborators
- Pakistani Society of Neuroradiology, Middle East North Africa Stroke and Interventional Neurotherapies Organization, Egyptian Stroke Society, African Academy of neurology, Egyptian Society for Progenitor Cell Research
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A double blind, randomized, controlled investigational study
| Arm | Type | Receives |
|---|---|---|
| group A | Sham comparator | Procedure: mechanical thrombectomyinclude 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 | Experimental | Procedure: mechanical thrombectomyinclude all clots which have been extracted by mechanical thrombectomy and with unknown stroke etiology and submitted to RNA analysis in cryptogenic label. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical thrombectomyAlso: RNA Sequencing AnalysisMechanical 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. | Procedure or surgery | group A, group B |
Primary outcome
Mrs
Time frame: 30 days
Modified ranking scale
1 secondary outcome
Sensitivity & Specificity
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Foad Abd-allah, MD,PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical thrombectomy in people with Stroke, Acute and Thrombosis, run by Society of Minimally Invasive Neurological Therapeutic Procedures at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ossama mansour, MD, PhD (00201223926932, yassinossama@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mrs (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.