NCT02964052

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. 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. Investigators will firstly establish the CT-based scores and comorbidity index using a pre-existing cohort database. Using these CT-based and comorbidity index, Investigators will validate them in a multi-center prospectively cohort. In addition, Investigators will assess the cost-effectiveness of selecting patients based on the comorbidity index.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,359

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

November 18, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2020

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

3.7 years

First QC Date

November 7, 2016

Last Update Submit

December 25, 2022

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (12)

  • Modified Rankin scale scores

    3 months after discharge day

  • Death

    6 months after discharge day

  • National Institutes of Health Stroke Scale (NIHSS) scores

    1 hr after IV rt-PA infusion

  • Recanalization rate

    after 16 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)

  • Recanalization rate

    after 24 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)

  • Recanalization rate

    after 32 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)

  • Symptomatic hemorrhagic transformation rate

    after 16 hrs thrombolytic treatments in MR or CT

  • Symptomatic hemorrhagic transformation rate

    after 24 hrs thrombolytic treatments in MR or CT

  • Symptomatic hemorrhagic transformation rate

    after 32 hrs thrombolytic treatments in MR or CT

  • asymptomatic hemorrhagic transformation rate

    after 16 hrs thrombolysis in MR or CT

  • asymptomatic hemorrhagic transformation rate

    after 24 hrs thrombolysis in MR or CT

  • asymptomatic hemorrhagic transformation rate

    after 32 hrs thrombolysis in MR or CT

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 imagingOTHER

Investigators will analyzed the CT image that was performed in patients with hyperacute stroke. The CT protocol includes CT thrombus, collateral, core images. Investigators also obtain detailed history and laboratory and imaging result for comorbidity. The comorbidity index protocol is based on the Charlson comorbidity index.

Acute ischemic stroke patients

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (2)

  • Nam HS, Kim YD, Yoo J, Park H, Kim BM, Bang OY, Kim HC, Han E, Kim DJ, Lee IH, Lee H, Choi JK, Lee KY, Lee HS, Shin DH, Choi HY, Sohn SI, Hong JH, Lee JY, Baek JH, Kim GS, Seo WK, Chung JW, Kim SH, Song TJ, Han SW, Park JH, Kim J, Jung YH, Cho HJ, Ahn SH, Seo KD, Lee KO, Song J, Heo JH. d-Dimer Level After Endovascular Treatment Can Help Predict Outcome of Acute Ischemic Stroke. Stroke Vasc Interv Neurol. 2023 Feb 25;3(3):e000713. doi: 10.1161/SVIN.122.000713. eCollection 2023 May.

    PMID: 41584989DERIVED

  • Kim HJ, Park MS, Yoo J, Kim YD, Park H, Kim BM, Bang OY, Kim HC, Han E, Kim DJ, Heo J, Choi JK, Lee KY, Lee HS, Shin DH, Choi HY, Sohn SI, Hong JH, Lee JY, Baek JH, Kim GS, Seo WK, Chung JW, Kim SH, Han SW, Park JH, Kim J, Jung YH, Cho HJ, Ahn SH, Lee SI, Seo KD, Chang Y, Song TJ, Nam HS; SECRET Study Investigators. Association between CHADS2, CHA2DS2-VASc, ATRIA, and Essen Stroke Risk Scores and Unsuccessful Recanalization after Endovascular Thrombectomy in Acute Ischemic Stroke Patients. J Clin Med. 2022 Jan 5;11(1):274. doi: 10.3390/jcm11010274.

    PMID: 35012015DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 15, 2016

Study Start

November 18, 2016

Primary Completion

August 3, 2020

Study Completion

August 3, 2020

Last Updated

December 28, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)