Clinical trial NCT02964052: Selection Criteria in Endovascular Thrombectomy and Thrombolytic Therapy (SECRET) Study: Development of Patient Selection Criteria Using CT Images and Accompanying Diseases for Efficient Intravenous Thrombolytic and Intra-arterial Recanalization Therapy in Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 1359
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Modified Rankin scale scores
timeFrame: 3 months after discharge day
measure: Death
timeFrame: 6 months after discharge day
measure: National Institutes of Health Stroke Scale (NIHSS) scores
timeFrame: 1 hr after IV rt-PA infusion
measure: Recanalization rate
timeFrame: after 16 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
measure: Recanalization rate
timeFrame: after 24 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
measure: Recanalization rate
timeFrame: after 32 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
measure: Symptomatic hemorrhagic transformation rate
timeFrame: after 16 hrs thrombolytic treatments in MR or CT
measure: Symptomatic hemorrhagic transformation rate
timeFrame: after 24 hrs thrombolytic treatments in MR or CT
measure: Symptomatic hemorrhagic transformation rate
timeFrame: after 32 hrs thrombolytic treatments in MR or CT
measure: asymptomatic hemorrhagic transformation rate
timeFrame: after 16 hrs thrombolysis in MR or CT
measure: asymptomatic hemorrhagic transformation rate
timeFrame: after 24 hrs thrombolysis in MR or CT
measure: asymptomatic hemorrhagic transformation rate
timeFrame: after 32 hrs thrombolysis in MR or CT
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Yonsei University College of Medicine
Study officials:
References:
citation: 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.