Clinical trial NCT05644938: Optimizing Door-to-reperfusion Times of One-stop Management in Acute Ischemic Stroke
Official title: Optimizing Door-to-reperfusion Times of One-stop Management in Acute Ischemic Stroke Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
angiosuite
reperfusion times
One-stop
Lead sponsor: Can Tho Stroke International Services Hospital
Sponsor class: OTHER
Collaborators: name: Siemens Healthineers AG
First posted: 2022-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, controlled, single blind when patients are only blinded to the allocation, our clinical trial was conducted comparing One-stop (OS) management with our standard workflow (SW) in treatment of acute ischemic stroke from 12/2022 - 11/2023 at Can Tho SIS General Hospital. Patients were enrolled according to 1:1 enroll ratio (OS: SW). The OS group transferred directly to biplane flat panel detector computed tomography perfusion (FD-CTP) to consider recanalization by either intervention or recombinant Tissue Plasminogen Activator (rTPA) in the angiosuite, whereas the SW group was either transferred to angiosuite or received rTPA, if indicated, after the results of Magnetic resonance imaging (MRI) and Magnetic resonance angiography (MRA) at admission
Primary purpose: TREATMENT

Brief summary: Time is one of the most important in the decision of treatment of acute ischemic stroke. The optimal One-stop management from admission to recanalization associated with reduction of in-hospital times. The development of ﬂat-detector computed tomography perfusion capable angio-suite allowed One-stop management to be improved treatment time better and better. To compare One-stop management versus our standard workflow in shortening door-to-recanalization time.

Detailed description: Acute ischemic stroke is one of the diseases associated with stroke onset time, especially in the case of large vessel occlusion within 6 hours. This is the reason why endovascular reperfusion therapy (mechanical thrombectomy, angioplasty, stent,...) is recommended to be performed as soon as possible in the comprehensive stroke centers. The successful recanalization within 6 hours demonstrated the efficacy that helps to improve the functional outcome by trials. Besides, the strategies shortening time from admission to successful recanalization are essential for the treatment of acute ischemic stroke due to large vessel occlusion. Nevertheless, the optimizing door-to-groin puncture and door to recanalization Time are the great challenge to benefit most patients with the endovascular therapy. In recent years, the One - stop management (direct transport to the angiosuite workflow) which means that the recanalization therapy is considered to perform immediately based on the diagnostic angiograms and perfusion maps relating to acute ischemic stroke caused by large vessel occlusion by the ﬂat-detector computed tomography at the angiosuite at the same time. We hypothesized that one-stop management is feasible and reduces more intrahospital time delays than our standard workflow previously published.

Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke in the anterior circulation caused by large vessel occlusion.
* National Institute of Health Stroke Scale (NIHSS) ≥10.
* Premorbid modified Rankin Scale (mRS) ≤ 2
* Target Mismatch profile: CBF \< 30% volume \< 100ml, Mismatch volume ≥ 15 ml and Mismatch Ratio \>1.8.
* Available angiosuite.
* CBF \< 30% volume: 70 - 100 ml when non-contrast computed tomography (NCCT) Alberta Stroke Program Early Computed Tomography Scores (ASPECTS) was 3 - 5 and/or beyond 6 hours after symptom onset

Exclusion Criteria:

* Evidence of intracranial tumors, the encephalitis, the hemorrhage: either an intracranial hemorrhage (ICH) or subarachnoid hemorrhage (SAH) by the biplane flat panel detector computed tomography.
* Participated in another studies.
* Loss to follow-up after discharge.
* A severe or fatal combined illness before acute stroke.

Primary outcomes:
measure: Door-to-reperfusion times
timeFrame: 1 day (During intrahospital)
measure: Functional 3 - month outcome rate
timeFrame: 3 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cần Thơ
country: Vietnam
facility: Can Tho SIS Hospital
Study officials:
affiliation: Can Tho Stroke International Services General Hospital
name: Cuong C Tran, PhD
role: STUDY_DIRECTOR
References:
citation: Requena M, Olive-Gadea M, Muchada M, Hernandez D, Rubiera M, Boned S, Pinana C, Deck M, Garcia-Tornel A, Diaz-Silva H, Rodriguez-Villatoro N, Juega J, Rodriguez-Luna D, Pagola J, Molina C, Tomasello A, Ribo M. Direct to Angiography Suite Without Stopping for Computed Tomography Imaging for Patients With Acute Stroke: A Randomized Clinical Trial. JAMA Neurol. 2021 Sep 1;78(9):1099-1107. doi: 10.1001/jamaneurol.2021.2385.
citation: Kurmann CC, Kaesmacher J, Cooke DL, Psychogios M, Weber J, Lopes DK, Albers GW, Mordasini P. Evaluation of time-resolved whole brain flat panel detector perfusion imaging using RAPID ANGIO in patients with acute stroke: comparison with CT perfusion imaging. J Neurointerv Surg. 2023 Apr;15(4):387-392. doi: 10.1136/neurintsurg-2021-018464. Epub 2022 Apr 8.
citation: Brehm A, Tsogkas I, Maier IL, Eisenberg HJ, Yang P, Liu JM, Liman J, Psychogios MN. One-Stop Management with Perfusion for Transfer Patients with Stroke due to a Large-Vessel Occlusion: Feasibility and Effects on In-Hospital Times. AJNR Am J Neuroradiol. 2019 Aug;40(8):1330-1334. doi: 10.3174/ajnr.A6129. Epub 2019 Jul 11.