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

NCT04066556 | Active Not Recruiting DMC

• 1 other identifier: 4-2019-0486
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Stroke; Recanalization treatment; Outcome; Collateral; Thrombus; CT; Comorbidity

Outcome Measures

Primary Outcomes (6)

• 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 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

  at 3 months

• Any death

  Any death within 6 months

  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))

  at 1 day

• Recanalization rate

  Recanalization rate after thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA) at 24 hours ± 8 hours

  at 24 hours ± 8 hours

• Asymptomatic hemorrhagic transformation rate

  Hemorrhagic transformation rate after thrombolysis in MR or CT at 24 hours ± 8 hours

  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

  within 7 days

Secondary Outcomes (2)

• Causes of deaths

  within 6 month

• Stroke subtypes

  within 7 days

Study Arms (1)

Acute ischemic stroke patients

Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment

Other: Brain CT imaging

Interventions

Brain CT imaging OTHER

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.

Acute ischemic stroke patients

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Neurology, Yonsei University College of Medicine

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, frozen tissue

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Thrombosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: July 12, 2019
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

KR (1)