Ischemic StrokeNCT04066556
SMART-EST(Specialized Multi-center Attributed Registry of sTroke - EndovaScular or Thrombolytic Therapy)
An observational study of Ischemic Stroke, run by Yonsei University at 1 site in South Korea.
Trial summary
Use of intravenous(IV) thrombolysis and intra-arterial(IA) recanalization treatment has been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 - 70% and only 30-50% of patients show meaningful clinical improvements. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Brain CT imaging
- Type of treatment
- Injection or infusion
- How many people
- 5,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2019to Jun 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment
Who may be able to join
- Age ≥20 years old
- Acute ischemic stroke patients who underwent CT angiographies before IV thrombolysis and/or IA recanalization treatment
- Patients who give an informed consents for participation in the study or the legal representative or immediate family give informed consent on behalf of patients in case of difficulty to decide study enrollment.
Who cannot join
- Age <20 years old
- Acute ischemic stroke patients who did not receive IV thrombolysis and/or IA recanalization treatment
- No informed consents from patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Neurology, Yonsei University College of Medicine
Seoul
About this study
Official title: Prospective Multicenter Registry for Acute Ischemic Stroke Patients With Standard Reperfusion Therapy
Use of intravenous(IV) thrombolysis and intra-arterial(IA) recanalization treatment has been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 - 70% and only 30-50% of patients show meaningful clinical improvements. Mechanisms of futile recanalization may include 1) large ischemic core, 2) poor collateral, and 3) presence of comorbidity. In this regards, developing selection criteria using acute stroke imaging and comorbidity is warranted.
The investigators will recruit the consecutive acute stroke patients who received IV thrombolysis and/or IA recanalization treatment. This study will perform with prospective design to develop CT-based clot, core and collateral scores and a comorbidity index for selecting stroke patients who are at high risks by the treatment. The investigators will firstly establish the CT-based scores and comorbidity index using a pre-existing cohort database. Using these CT-based and comorbidity index, the investigators will validate them in a multi-center prospectively cohort.
Read the detailed description
1)Full design
- The study proceeds with a parallel design of retrospective and prospective research.
- As in the retrospective study, this study aims to establish the ideal screening criteria and to verify the efficacy of the thrombolytic procedure by using the relevant image information, clinical information, and the history of the subjects.
- This study is an observational study, and there is no intervention for the study.
- retrospective design
- Retrospective study was conducted as a multi-center retrospective cohort and intravenous thrombolysis and intraarterial thrombus according to the guidelines for stroke among patients who were admitted to neurology with stroke from January 1, 2012 to December 31, 2015 of participating hospitals. Patients who underwent surgical removal.
- The retrospective study was performed after 3 months F / U and 6 months after confirming the medical history and clinical information taken before the thrombolysis and the accompanying disease history. Check whether or not.
- We will establish the most ideal screening criteria and verify the efficacy of predicting the prognosis after thrombolysis using the relevant imaging information, clinical information and the accompanying disease history.
- All data are collected using e-CRF, and CT angiography images of subjects are anonymized and sent to the host institution. The lead institution quantifies the clinical information, including CT angiographic indicators and accompanying diseases, in the dark.
- Interim analysis will be conducted once when the retrospective study is completed.
- prospective design
- A prospective study is a multicenter prospective observational study, in which intravenous thrombolysis and arteries were already followed in accordance with guidelines for stroke among patients who were admitted to neurology after a stroke on November 1, 2016 (based on hospitalization date). Patients who have undergone internal thrombectomy
- Obtain a written consent form from a study subject who meets the selection / exclusion criteria (see How to Obtain a Study Participation Consent Form), and collect the medical data including the accompanying diseases of the study subject and images taken before thrombosis (removal) treatment. do.
- In the same way as retrospective study, confirm and confirm the image and clinical information and the accompanying disease history of the study subjects and confirm the survival after 3 months F / U and 6 months.
- The observation period in the study is expected to take about 6 months (intravenous thrombolytic therapy and intraarterial reopening therapy, mRS indicator at 3 months after discharge and stroke, and survival at 6 months after stroke).
- All data are collected using eCRF, and CT angiography images of subjects are anonymized and sent to the host institution. The lead institution quantifies CT angiography and associated disease indicators with blinded clinical information.
- Screening (time of hospitalization due to stroke) Patients who had cerebrovascular pretreatment prior to intravenous thrombolysis and were able to identify comorbidities.
- Conditions
- Ischemic Stroke
- Being tested
- Brain CT imaging
- Keywords
- Stroke, Recanalization treatment, Outcome, Collateral, Thrombus, CT, Comorbidity
- Medical subject headings
- Ischemic Stroke, Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain CT imagingOther
The investigators will analyzed the CT image that was performed in patients with hyperacute stroke. The CT protocol includes CT thrombus, collateral, core images. The investigators also obtain detailed history and laboratory and imaging result for comorbidity. The comorbidity index protocol is based on the Charlson comorbidity index.
- Cut-off values in thrombus volume and Hounsfield unit according to non-contrast CT images
- Cut-off values in areas of irreversible changes according to non-contrast CT images
- Cut-off values in occlusion sites and collateral scores according to CT angiographies
- Cut-off values of consolidated CT imaging index including clot, core, and collateral score
- Cut-off values of comorbidity index
- Medical care expenses according to comorbidity index in patients who received intravenous thrombolytic treatment and/or endovascular recanalization treatments.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke patients | Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment Receives: Other: Brain CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin scale scores
Functional improvement after stroke at 3 months Scale range: 0(Best)~6(Worst) , Functional outcome measure in stroke. Levels of disability
0: No symptoms at all
- No significant disability : despite symptoms : able to carry out all usual duties and activities.
- Slight disability : unable to carry out all previous activities but able to look after own affairs without assistance.
- Moderate disability : requiring some help, but able to walk without assistance.
- Moderate severe disability : unable to walk without assistance, and unable to attend to own bodily needs without assistance.
- Severe disability : bedridden, incontinent and requiring constant nursing care and attention.
- Death
Measured: at 3 months
Any death
Any death within 6 months
Measured: within 6 months
National Institutes of Health Stroke Scale (NIHSS) scores
Primary Outcome Description: Neurological improvement according to NIHSS scores National Institutes of Health Stroke Scale (NIHSS) scores
The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. (total score : 0(good)~ 42(death))
Measured: at 1 day
Recanalization rate
Recanalization rate after thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA) at 24 hours ± 8 hours
Measured: at 24 hours ± 8 hours
Asymptomatic hemorrhagic transformation rate
Hemorrhagic transformation rate after thrombolysis in MR or CT at 24 hours ± 8 hours
Measured: at 24 hours ± 8 hours
Any complication rate including extracranial life-threatening bleeding, herniation, infection rate
Any complication rate including extracranial life-threatening bleeding, herniation, infection rate within 7 days
Measured: within 7 days
Secondary outcomes (2)
Causes of deaths
Causes of deaths after thrombolytic treatments within 6 month
Measured: within 6 month
Stroke subtypes
The Trial of ORG 10172 in Acute Stroke Treatment (TOAST) classification
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start12 Jul 2019
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066556
- Sponsor's protocol ID
- 4-2019-0486
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Registry for Acute Ischemic Stroke Patients With Standard Reperfusion Therapy
- ClinicalTrials.gov ID
- NCT04066556
- Acronym / sponsor ID
- 4-2019-0486
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Recanalization treatment, Outcome, Collateral, Thrombus, CT, Comorbidity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 26 Aug 2019 (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.
Use of intravenous(IV) thrombolysis and intra-arterial(IA) recanalization treatment has been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 - 70% and only 30-50% of patients show meaningful clinical improvements. Mechanisms of futile recanalization may include 1) large ischemic core, 2) poor collateral, and 3) presence of comorbidity. In this regards, developing selection criteria using acute stroke imaging and comorbidity is warranted.
The investigators will recruit the consecutive acute stroke patients who received IV thrombolysis and/or IA recanalization treatment. This study will perform with prospective design to develop CT-based clot, core and collateral scores and a comorbidity index for selecting stroke patients who are at high risks by the treatment. The investigators will firstly establish the CT-based scores and comorbidity index using a pre-existing cohort database. Using these CT-based and comorbidity index, the investigators will validate them in a multi-center prospectively cohort.
Detailed description
1)Full design
- The study proceeds with a parallel design of retrospective and prospective research.
- As in the retrospective study, this study aims to establish the ideal screening criteria and to verify the efficacy of the thrombolytic procedure by using the relevant image information, clinical information, and the history of the subjects.
- This study is an observational study, and there is no intervention for the study.
- retrospective design
- Retrospective study was conducted as a multi-center retrospective cohort and intravenous thrombolysis and intraarterial thrombus according to the guidelines for stroke among patients who were admitted to neurology with stroke from January 1, 2012 to December 31, 2015 of participating hospitals. Patients who underwent surgical removal.
- The retrospective study was performed after 3 months F / U and 6 months after confirming the medical history and clinical information taken before the thrombolysis and the accompanying disease history. Check whether or not.
- We will establish the most ideal screening criteria and verify the efficacy of predicting the prognosis after thrombolysis using the relevant imaging information, clinical information and the accompanying disease history.
- All data are collected using e-CRF, and CT angiography images of subjects are anonymized and sent to the host institution. The lead institution quantifies the clinical information, including CT angiographic indicators and accompanying diseases, in the dark.
- Interim analysis will be conducted once when the retrospective study is completed.
- prospective design
- A prospective study is a multicenter prospective observational study, in which intravenous thrombolysis and arteries were already followed in accordance with guidelines for stroke among patients who were admitted to neurology after a stroke on November 1, 2016 (based on hospitalization date). Patients who have undergone internal thrombectomy
- Obtain a written consent form from a study subject who meets the selection / exclusion criteria (see How to Obtain a Study Participation Consent Form), and collect the medical data including the accompanying diseases of the study subject and images taken before thrombosis (removal) treatment. do.
- In the same way as retrospective study, confirm and confirm the image and clinical information and the accompanying disease history of the study subjects and confirm the survival after 3 months F / U and 6 months.
- The observation period in the study is expected to take about 6 months (intravenous thrombolytic therapy and intraarterial reopening therapy, mRS indicator at 3 months after discharge and stroke, and survival at 6 months after stroke).
- All data are collected using eCRF, and CT angiography images of subjects are anonymized and sent to the host institution. The lead institution quantifies CT angiography and associated disease indicators with blinded clinical information.
- Screening (time of hospitalization due to stroke) Patients who had cerebrovascular pretreatment prior to intravenous thrombolysis and were able to identify comorbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke patients | – | Other: Brain CT imagingAcute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment
Key inclusion criteria (3 listed)
- Age ≥20 years old
- Acute ischemic stroke patients who underwent CT angiographies before IV thrombolysis and/or IA recanalization treatment
- Patients who give an informed consents for participation in the study or the legal representative or immediate family give informed consent on behalf of patients in case of difficulty to decide study enrollment.
Key exclusion criteria (3 listed)
- Age <20 years old
- Acute ischemic stroke patients who did not receive IV thrombolysis and/or IA recanalization treatment
- No informed consents from patients
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 |
|---|---|---|
| Brain CT imagingThe investigators will analyzed the CT image that was performed in patients with hyperacute stroke. The CT protocol includes CT thrombus, collateral, core images. The investigators also obtain detailed history and laboratory and imaging result for comorbidity. The comorbidity index protocol is based on the Charlson comorbidity index. * Cut-off values in thrombus volume and Hounsfield unit according to non-contrast CT images * Cut-off values in areas of irreversible changes according to non-contrast CT images * Cut-off values in occlusion sites and collateral scores according to CT angiographies * Cut-off values of consolidated CT imaging index including clot, core, and collateral score * Cut-off values of comorbidity index * Medical care expenses according to comorbidity index in patients who received intravenous thrombolytic treatment and/or endovascular recanalization treatments. | Other | Acute ischemic stroke patients |
Primary outcome
Modified Rankin scale scores
Time frame: at 3 months
Functional improvement after stroke at 3 months Scale range: 0(Best)~6(Worst) , Functional outcome measure in stroke. Levels of disability 0: No symptoms at all 1. No significant disability : despite symptoms : able to carry out all usual duties and activities. 2. Slight disability : unable to carry out all previous activities but able to look after own affairs without assistance. 3. Moderate disability : requiring some help, but able to walk without assistance. 4. Moderate severe disability : unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5. Severe disability : bedridden, incontinent and requiring constant nursing care and attention. 6. Death
Any death
Time frame: within 6 months
Any death within 6 months
National Institutes of Health Stroke Scale (NIHSS) scores
Time frame: at 1 day
Primary Outcome Description: Neurological improvement according to NIHSS scores National Institutes of Health Stroke Scale (NIHSS) scores The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. (total score : 0(good)~ 42(death))
Recanalization rate
Time frame: at 24 hours ± 8 hours
Recanalization rate after thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA) at 24 hours ± 8 hours
Asymptomatic hemorrhagic transformation rate
Time frame: at 24 hours ± 8 hours
Hemorrhagic transformation rate after thrombolysis in MR or CT at 24 hours ± 8 hours
Any complication rate including extracranial life-threatening bleeding, herniation, infection rate
Time frame: within 7 days
Any complication rate including extracranial life-threatening bleeding, herniation, infection rate within 7 days
2 secondary outcomes
Causes of deaths
Time frame: within 6 month
Stroke subtypes
Time frame: within 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2019. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
Modified Rankin scale scores (time frame: at 3 months). The study lists 6 primary outcomes in all. 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 28 Aug 2019.