StrokeSELECTNCT02446587
Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
An observational study of Stroke and Ischemic Stroke, run by The University of Texas Health Science Center, Houston at 9 sites in United States.
Trial summary
SELECT is a multicenter, observational prospective study implementing a protocol to acquire imaging and clinical variables known to affect clinical outcomes after endovascular therapy in an effort to evaluate and compare the different selection methods and criteria currently used in practice for acute ischemic stroke… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic Stroke
- What is being tested?
- Mechanical Thrombectomy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 500 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2016to May 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be adults (≥18 with the final diagnosis of an acute ischemic infarction and large artery occlusion in anterior circulation strokes). Given the observational design of the study there will be no stringent exclusion based on stroke severity or IV tPA treatment
Who may be able to join
- Eligible patients will be:
- Adults (≥18years) with the final diagnosis of an acute ischemic stroke
- CT-Angiogram proven, large artery occlusion (LAO) in the internal carotid artery (ICA), middle cerebral artery (MCA -M1 or M2 site) locations
- NIH Stroke Scale ≥6 (NIHSS) OR proven LAO on imaging (must be from designated LAO listed on inclusion #2)
- LSN (last seen normal) to groin puncture (≤ 8 hours) in thrombectomy arm; LSN to presentation to endovascular capable center (≤ 8 hours) in medical arm
- Baseline modified Rankin Scale score of 0-1
Show all 10Show fewer
- Signed Informed Consent obtained
- Subject willing to comply with the protocol follow-up requirements
- Anticipated life expectancy of at least 3 months
- IV-tPA eligible patients must meet AHA guidelines
Who cannot join
- Patients are excluded if:
- Inability to undergo CT-Angiography and/or CT-Perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
- Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
- Subject is participating in another mechanical neuro-thrombectomy device trial (intervention) or any other trial where the study procedure or treatment might confound the study endpoint.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory University
Atlanta, Georgia, 30322
Riverside Methodist Hospital
Columbus, Ohio, 43214
Valley Baptist Medical Center
Harlingen, Texas, 78550
UTHealth Science Center
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
WellStar Health System
Marietta, Georgia, 30066
Florida Hospital
Orlando, Florida, 32803
St. Louis University
St Louis, Missouri, 78550
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT)
SELECT is a multicenter, observational prospective study implementing a protocol to acquire imaging and clinical variables known to affect clinical outcomes after endovascular therapy in an effort to evaluate and compare the different selection methods and criteria currently used in practice for acute ischemic stroke patients in the anterior circulation with large vessel occlusion. The study aim is to evaluate prospectively different selection methodologies for endovascular therapy, to compare them against each other to identify which method provides the highest predictive ability in the selection of patients for IAT and to devise a formula that predicts patients' outcomes.
This study will enroll patients based on the recent AHA guidelines (July 2015) regarding treatment of patients with acute ischemic strokes and large artery occlusions in the anterior circulation.
Our goal is to collect complete imaging, clinical, and 90 day follow up data on 250 endovascular therapy patients as well as up to 250 concurrent medical management patients as a comparison group.
Read the detailed description
Improving reperfusion status is the most effective therapeutic approach for patients with acute ischemic strokes (AIS) due to large artery occlusion (LAO). Intra-Arterial Therapy (IAT) by means of mechanical thrombectomy and/or chemical fibrinolysis has been adopted worldwide to recanalize LAO strokes. IAT is now the standard of care for AIS patients with LAO based on the results of five randomized clinical trials. However, these trials implemented different imaging methodologies for patient treatment with IAT. Specially, these trials were designed to use one or another selection methodology without knowing which may be superior and more effective in selecting patients that may or may not benefit from the intervention.
Decisions to pursue IAT are clinician-dependent and rest upon a number of different factors that may differ from one center to another and even in the same center from one treating physician to another. The Alberta Stroke Program Early CT Score (ASPECTS) has demonstrated utility in selecting candidates for recanalization strategies using a simple noncontrast head CT (NCCT). Numerous other studies suggest the utility of magnetic resonance imaging (MRI), CT angiography (CTA) and CT perfusion in identifying patients who have poor outcome after thrombolysis.
However, the current widely practiced selection methodologies have never been tested against one another in the context of a prospective trial to evaluate their sensitivity, specificity and superiority, which is in our opinion (and shared by many treating vascular neurologists), a major question that is being asked on daily basis by the treating physicians. Furthermore, prognostication and informing stroke patients' families of their chances of having good outcomes after Intra-Arterial Therapy is crucial and depends to a large extent on the clinical and imaging variables utilized prior to IAT as well as on the success of the intervention itself.
- Conditions
- Stroke, Ischemic Stroke
- Being tested
- Mechanical Thrombectomy
- Keywords
- endovascular therapy, thrombectomy, selection, imaging, perfusion, collaterals, ASPECTS
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ThrombectomyDevice
Also called Endovascular Therapy, Intraarterial Therapy (IAT)
Mechanical thrombectomy includes the use of stent retrievers (i.e. Trevo®, Solitaire®, or other stent retriever devices) as recommended by AHA guidelines (July 2015). A stent retriever is delivered directly to a thromboembolus that is occluding a cerebral artery to restore blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Stroke with Mechanical Thrombectomy | Eligible patients will be adults ≥18 with the final diagnosis of an acute ischemic infarction and large artery occlusion in anterior circulation strokes who undergo endovascular therapy with mechanical thrombectomy utilizing stent retrievers Receives: Device: Mechanical Thrombectomy | |
| Stroke without Mechanical Thrombectomy | Patients who would have large artery occlusion treated with best medical management (IV-tPA if eligible) and not receiving endovascular therapy will be collected for a secondary analysis as a comparison group and to evaluate the selection methods in them as well |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 90 modified Rankin scale
Favorable primary clinical outcome will be patients functional outcomes at 90 (+/- 15) days measured by modified Rankin scale (mRS) score 0-2
Measured: 90 Days
Secondary outcomes (2)
Safety (incidence of: hemorrhage; mortality; hematoma, infection, vascular injury)
Safety as measured by the incidence rate
Measured: 90 Days
Rates of recanalization
rates of recanalization (using modified TICI score) will be measured after patient's have undergone endovascular therapy
Measured: post-procedure (expected average of 6-12hrs after hospital admittance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Neurovascular, WellStar Health System, AdventHealth, Emory University, Riverside Methodist Hospital, Valley Baptist Medical Center, St. Louis University, University of Kansas, Stanford University
- Responsible party
- Principal investigator, Amrou Sarraj, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446587
- Sponsor's protocol ID
- SELECT
- Acronym
- SELECT
- Status last verified
- Apr 2019
- First submitted
- 8 May 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sarraj A, Albers GW, Mitchell PJ, Hassan AE, Abraham MG, Blackburn S, Sharma G, Yassi N, Kleinig TJ, Shah DG, Wu TY, Hussain MS, Tekle WG, Gutierrez SO, Aghaebrahim AN, Haussen DC, Toth G, Pujara D, Budzik RF, Hicks W, Vora N, Edgell RC, Slavin S, Lechtenberg CG, Maali L, Qureshi A, Rosterman L, Abdulrazzak MA, AlMaghrabi T, Shaker F, Mir O, Arora A, Martin-Schild S, Sitton CW, Churilov L, Gupta R, Lansberg MG, Nogueira RG, Grotta JC, Donnan GA, Davis SM, Campbell BCV; SELECT, EXTEND-IA, EXTEND-IA TNK, and EXTEND-IA TNK Part-II Investigators. Thrombectomy Outcomes With General vs Nongeneral Anesthesia: A Pooled Patient-Level Analysis From the EXTEND-IA Trials and SELECT Study. Neurology. 2023 Jan 17;100(3):e336-e347. doi: 10.1212/WNL.0000000000201384. Epub 2022 Oct 26.
PubMed 36289001Fifi JT, Nguyen TN, Song S, Sharrief A, Pujara DK, Shaker F, Fournier LE, Jones EM, Lechtenberg CG, Slavin SJ, Ifejika NL, Diaz MV, Martin-Schild S, Schaafsma J, Tsai JP, Alexandrov AW, Tjoumakaris SI, Sarraj A; SELECT Investigators. Sex differences in endovascular thrombectomy outcomes in large vessel occlusion: a propensity-matched analysis from the SELECT study. J Neurointerv Surg. 2023 Feb;15(2):105-112. doi: 10.1136/neurintsurg-2021-018348. Epub 2022 Mar 1.
PubMed 35232756Sarraj A, Grotta J, Albers GW, Hassan AE, Blackburn S, Day A, Sitton C, Abraham M, Cai C, Dannenbaum M, Pujara D, Hicks W, Budzik R, Vora N, Arora A, Alenzi B, Tekle WG, Kamal H, Mir O, Barreto AD, Lansberg M, Gupta R, Martin-Schild S, Savitz S, Tsivgoulis G; SELECT Investigators. Clinical and Neuroimaging Outcomes of Direct Thrombectomy vs Bridging Therapy in Large Vessel Occlusion: Analysis of the SELECT Cohort Study. Neurology. 2021 Jun 8;96(23):e2839-e2853. doi: 10.1212/WNL.0000000000012063. Epub 2021 Apr 19.
PubMed 33875560Sarraj A, Hassan AE, Grotta J, Blackburn S, Day A, Abraham M, Sitton C, Dannenbaum M, Cai C, Pujara D, Hicks W, Vora N, Budzik R, Shaker F, Arora A, Riascos RF, Kamal H, Martin-Schild S, Lansberg M, Gupta R, Albers GW; SELECT Investigators. Early Infarct Growth Rate Correlation With Endovascular Thrombectomy Clinical Outcomes: Analysis From the SELECT Study. Stroke. 2021 Jan;52(1):57-69. doi: 10.1161/STROKEAHA.120.030912. Epub 2020 Dec 7.
PubMed 33280550Sarraj A, Pizzo E, Lobotesis K, Grotta JC, Hassan AE, Abraham MG, Blackburn S, Day AL, Dannenbaum MJ, Hicks W, Vora NA, Budzik RF, Sharrief AZ, Martin-Schild S, Sitton CW, Pujara DK, Lansberg MG, Gupta R, Albers GW, Kunz WG; SELECT Investigators. Endovascular thrombectomy in patients with large core ischemic stroke: a cost-effectiveness analysis from the SELECT study. J Neurointerv Surg. 2021 Oct;13(10):875-882. doi: 10.1136/neurintsurg-2020-016766. Epub 2020 Nov 13.
PubMed 33188155Sarraj A, Hassan AE, Grotta J, Sitton C, Cutter G, Cai C, Chen PR, Imam B, Pujara D, Arora A, Reddy S, Parsha K, Riascos RF, Vora N, Abraham M, Edgell R, Hellinger F, Haussen DC, Blackburn S, Kamal H, Barreto AD, Martin-Schild S, Lansberg M, Gupta R, Savitz S, Albers GW. Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT): A Prospective, Multicenter Cohort Study of Imaging Selection. Ann Neurol. 2020 Mar;87(3):419-433. doi: 10.1002/ana.25669. Epub 2020 Jan 21.
PubMed 31916270
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT)
- ClinicalTrials.gov ID
- NCT02446587
- Acronym / sponsor ID
- SELECT / SELECT
- Conditions
- Stroke, Ischemic Stroke
- Keywords
- endovascular therapy, thrombectomy, selection, imaging, perfusion, collaterals, ASPECTS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Stryker Neurovascular, WellStar Health System, AdventHealth, Emory University, Riverside Methodist Hospital, Valley Baptist Medical Center, St. Louis University, University of Kansas, Stanford University
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 18 May 2015 (estimated)
- 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.
SELECT is a multicenter, observational prospective study implementing a protocol to acquire imaging and clinical variables known to affect clinical outcomes after endovascular therapy in an effort to evaluate and compare the different selection methods and criteria currently used in practice for acute ischemic stroke patients in the anterior circulation with large vessel occlusion. The study aim is to evaluate prospectively different selection methodologies for endovascular therapy, to compare them against each other to identify which method provides the highest predictive ability in the selection of patients for IAT and to devise a formula that predicts patients' outcomes.
This study will enroll patients based on the recent AHA guidelines (July 2015) regarding treatment of patients with acute ischemic strokes and large artery occlusions in the anterior circulation.
Our goal is to collect complete imaging, clinical, and 90 day follow up data on 250 endovascular therapy patients as well as up to 250 concurrent medical management patients as a comparison group.
Detailed description
Improving reperfusion status is the most effective therapeutic approach for patients with acute ischemic strokes (AIS) due to large artery occlusion (LAO). Intra-Arterial Therapy (IAT) by means of mechanical thrombectomy and/or chemical fibrinolysis has been adopted worldwide to recanalize LAO strokes. IAT is now the standard of care for AIS patients with LAO based on the results of five randomized clinical trials. However, these trials implemented different imaging methodologies for patient treatment with IAT. Specially, these trials were designed to use one or another selection methodology without knowing which may be superior and more effective in selecting patients that may or may not benefit from the intervention.
Decisions to pursue IAT are clinician-dependent and rest upon a number of different factors that may differ from one center to another and even in the same center from one treating physician to another. The Alberta Stroke Program Early CT Score (ASPECTS) has demonstrated utility in selecting candidates for recanalization strategies using a simple noncontrast head CT (NCCT). Numerous other studies suggest the utility of magnetic resonance imaging (MRI), CT angiography (CTA) and CT perfusion in identifying patients who have poor outcome after thrombolysis.
However, the current widely practiced selection methodologies have never been tested against one another in the context of a prospective trial to evaluate their sensitivity, specificity and superiority, which is in our opinion (and shared by many treating vascular neurologists), a major question that is being asked on daily basis by the treating physicians. Furthermore, prognostication and informing stroke patients' families of their chances of having good outcomes after Intra-Arterial Therapy is crucial and depends to a large extent on the clinical and imaging variables utilized prior to IAT as well as on the success of the intervention itself.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke with Mechanical Thrombectomy | – | Device: Mechanical ThrombectomyEligible patients will be adults ≥18 with the final diagnosis of an acute ischemic infarction and large artery occlusion in anterior circulation strokes who undergo endovascular therapy with mechanical thrombectomy utilizing stent retrievers |
| Stroke without Mechanical Thrombectomy | – | –Patients who would have large artery occlusion treated with best medical management (IV-tPA if eligible) and not receiving endovascular therapy will be collected for a secondary analysis as a comparison group and to evaluate the selection methods in them as well |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be adults (≥18 with the final diagnosis of an acute ischemic infarction and large artery occlusion in anterior circulation strokes). Given the observational design of the study there will be no stringent exclusion based on stroke severity or IV tPA treatment
Key inclusion criteria (10 listed)
- Adults (≥18years) with the final diagnosis of an acute ischemic stroke
- CT-Angiogram proven, large artery occlusion (LAO) in the internal carotid artery (ICA), middle cerebral artery (MCA -M1 or M2 site) locations
- NIH Stroke Scale ≥6 (NIHSS) OR proven LAO on imaging (must be from designated LAO listed on inclusion #2)
- LSN (last seen normal) to groin puncture (≤ 8 hours) in thrombectomy arm; LSN to presentation to endovascular capable center (≤ 8 hours) in medical arm
- Baseline modified Rankin Scale score of 0-1
Key exclusion criteria (4 listed)
- Inability to undergo CT-Angiography and/or CT-Perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
- Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
- Subject is participating in another mechanical neuro-thrombectomy device trial (intervention) or any other trial where the study procedure or treatment might confound the study endpoint.
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: Endovascular Therapy, Intraarterial Therapy (IAT)Mechanical thrombectomy includes the use of stent retrievers (i.e. Trevo®, Solitaire®, or other stent retriever devices) as recommended by AHA guidelines (July 2015). A stent retriever is delivered directly to a thromboembolus that is occluding a cerebral artery to restore blood flow. | Device | Stroke with Mechanical Thrombectomy |
Primary outcome
Day 90 modified Rankin scale
Time frame: 90 Days
Favorable primary clinical outcome will be patients functional outcomes at 90 (+/- 15) days measured by modified Rankin scale (mRS) score 0-2
2 secondary outcomes
Safety (incidence of: hemorrhage; mortality; hematoma, infection, vascular injury)
Time frame: 90 Days
Rates of recanalization
Time frame: post-procedure (expected average of 6-12hrs after hospital admittance)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 36289001Sarraj A, Albers GW, Mitchell PJ, Hassan AE, Abraham MG, Blackburn S, Sharma G, Yassi N, Kleinig TJ, Shah DG, Wu TY, Hussain MS, Tekle WG, Gutierrez SO, Aghaebrahim AN, Haussen DC, Toth G, Pujara D, Budzik RF, Hicks W, Vora N, Edgell RC, Slavin S, Lechtenberg CG, Maali L, Qureshi A, Rosterman L, Abdulrazzak MA, AlMaghrabi T, Shaker F, Mir O, Arora A, Martin-Schild S, Sitton CW, Churilov L, Gupta R, Lansberg MG, Nogueira RG, Grotta JC, Donnan GA, Davis SM, Campbell BCV; SELECT, EXTEND-IA, EXTEND-IA TNK, and EXTEND-IA TNK Part-II Investigators. Thrombectomy Outcomes With General vs Nongeneral Anesthesia: A Pooled Patient-Level Analysis From the EXTEND-IA Trials and SELECT Study. Neurology. 2023 Jan 17;100(3):e336-e347. doi: 10.1212/WNL.0000000000201384. Epub 2022 Oct 26.
- Derived from this study: PubMed 35232756Fifi JT, Nguyen TN, Song S, Sharrief A, Pujara DK, Shaker F, Fournier LE, Jones EM, Lechtenberg CG, Slavin SJ, Ifejika NL, Diaz MV, Martin-Schild S, Schaafsma J, Tsai JP, Alexandrov AW, Tjoumakaris SI, Sarraj A; SELECT Investigators. Sex differences in endovascular thrombectomy outcomes in large vessel occlusion: a propensity-matched analysis from the SELECT study. J Neurointerv Surg. 2023 Feb;15(2):105-112. doi: 10.1136/neurintsurg-2021-018348. Epub 2022 Mar 1.
- Derived from this study: PubMed 33875560Sarraj A, Grotta J, Albers GW, Hassan AE, Blackburn S, Day A, Sitton C, Abraham M, Cai C, Dannenbaum M, Pujara D, Hicks W, Budzik R, Vora N, Arora A, Alenzi B, Tekle WG, Kamal H, Mir O, Barreto AD, Lansberg M, Gupta R, Martin-Schild S, Savitz S, Tsivgoulis G; SELECT Investigators. Clinical and Neuroimaging Outcomes of Direct Thrombectomy vs Bridging Therapy in Large Vessel Occlusion: Analysis of the SELECT Cohort Study. Neurology. 2021 Jun 8;96(23):e2839-e2853. doi: 10.1212/WNL.0000000000012063. Epub 2021 Apr 19.
- Derived from this study: PubMed 33280550Sarraj A, Hassan AE, Grotta J, Blackburn S, Day A, Abraham M, Sitton C, Dannenbaum M, Cai C, Pujara D, Hicks W, Vora N, Budzik R, Shaker F, Arora A, Riascos RF, Kamal H, Martin-Schild S, Lansberg M, Gupta R, Albers GW; SELECT Investigators. Early Infarct Growth Rate Correlation With Endovascular Thrombectomy Clinical Outcomes: Analysis From the SELECT Study. Stroke. 2021 Jan;52(1):57-69. doi: 10.1161/STROKEAHA.120.030912. Epub 2020 Dec 7.
- Derived from this study: PubMed 33188155Sarraj A, Pizzo E, Lobotesis K, Grotta JC, Hassan AE, Abraham MG, Blackburn S, Day AL, Dannenbaum MJ, Hicks W, Vora NA, Budzik RF, Sharrief AZ, Martin-Schild S, Sitton CW, Pujara DK, Lansberg MG, Gupta R, Albers GW, Kunz WG; SELECT Investigators. Endovascular thrombectomy in patients with large core ischemic stroke: a cost-effectiveness analysis from the SELECT study. J Neurointerv Surg. 2021 Oct;13(10):875-882. doi: 10.1136/neurintsurg-2020-016766. Epub 2020 Nov 13.
- Derived from this study: PubMed 31916270Sarraj A, Hassan AE, Grotta J, Sitton C, Cutter G, Cai C, Chen PR, Imam B, Pujara D, Arora A, Reddy S, Parsha K, Riascos RF, Vora N, Abraham M, Edgell R, Hellinger F, Haussen DC, Blackburn S, Kamal H, Barreto AD, Martin-Schild S, Lansberg M, Gupta R, Savitz S, Albers GW. Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT): A Prospective, Multicenter Cohort Study of Imaging Selection. Ann Neurol. 2020 Mar;87(3):419-433. doi: 10.1002/ana.25669. Epub 2020 Jan 21.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Ischemic Stroke, run by The University of Texas Health Science Center, Houston at 9 sites in United States.
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 10 inclusion and 4 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: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 90 modified Rankin scale (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02446587, which also lists 6 linked publications.
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 16 Apr 2019.