MedTrace Logo

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

NCT04066556 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2019-08-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04066556 on ClinicalTrials.gov