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SMART-EST(Specialized Multi-center Attributed Registry of sTroke - EndovaScular or Thrombolytic Therapy)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066556
Recruitment Status : Active, not recruiting
First Posted : August 26, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief 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. 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.


Condition or disease Intervention/treatment
Ischemic Stroke Other: Brain CT imaging

Detailed Description:

1)Full design

  1. The study proceeds with a parallel design of retrospective and prospective research.
  2. 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.
  3. This study is an observational study, and there is no intervention for the study.

2) retrospective design

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Interim analysis will be conducted once when the retrospective study is completed.

3) prospective design

  1. 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
  2. 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.
  3. 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.
  4. 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).
  5. 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.
  6. Screening (time of hospitalization due to stroke) Patients who had cerebrovascular pretreatment prior to intravenous thrombolysis and were able to identify comorbidities.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Prospective Multicenter Registry for Acute Ischemic Stroke Patients With Standard Reperfusion Therapy
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : June 2029
Estimated Study Completion Date : June 2029

Group/Cohort Intervention/treatment
Acute ischemic stroke patients
Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment
Other: Brain CT imaging

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.




Primary Outcome Measures :
  1. 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

  2. Any death [ Time Frame: within 6 months ]
    Any death within 6 months

  3. 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))


  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. Causes of deaths [ Time Frame: within 6 month ]
    Causes of deaths after thrombolytic treatments within 6 month

  2. Stroke subtypes [ Time Frame: within 7 days ]
    The Trial of ORG 10172 in Acute Stroke Treatment (TOAST) classification


Biospecimen Retention:   Samples With DNA
whole blood, frozen tissue


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.


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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment
Criteria

Inclusion Criteria:

  1. Age ≥20 years old
  2. Acute ischemic stroke patients who underwent CT angiographies before IV thrombolysis and/or IA recanalization treatment
  3. 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.

Exclusion Criteria:

  1. Age <20 years old
  2. Acute ischemic stroke patients who did not receive IV thrombolysis and/or IA recanalization treatment
  3. No informed consents from patients

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): NCT04066556


Locations
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Korea, Republic of
Department of Neurology, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04066556    
Other Study ID Numbers: 4-2019-0486
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Stroke
Recanalization treatment
Outcome
Collateral
Thrombus
CT
Comorbidity
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes