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Optimizing Door-to-reperfusion Times of One-stop Management in Acute Ischemic Stroke

NCT ID: NCT05644938

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Acute Ischemic Stroke

Keywords

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acute ischemic stroke angiosuite reperfusion times One-stop

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients are only blinded to the allocation.

Study Groups

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Standard workflow (SW)

Acute ischemic stroke caused by large vessel occlusion was diagnosed by Magnetic resonance imaging (MRI) and Magnetic resonance angiography (MRA) at admission in MRI room + Recanalization therapy in angiosuite

Group Type ACTIVE_COMPARATOR

Standard workflow

Intervention Type PROCEDURE

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.

One-stop (OS)

Acute ischemic stroke caused by large vessel occlusion was diagnosed + Recanalization therapy by the flat-detector computed tomography in angiosuite at the same time.

Group Type EXPERIMENTAL

One-stop

Intervention Type PROCEDURE

The OS group transferred directly to flat-detector computed tomography to consider recanalization by either intervention or recombinant Tissue Plasminogen Activator (rTPA) in the angiosuite.

Interventions

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Standard workflow

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.

Intervention Type PROCEDURE

One-stop

The OS group transferred directly to flat-detector computed tomography to consider recanalization by either intervention or recombinant Tissue Plasminogen Activator (rTPA) in the angiosuite.

Intervention Type PROCEDURE

Other Intervention Names

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SW OS

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Siemens Healthineers AG

UNKNOWN

Sponsor Role collaborator

Can Tho Stroke International Services Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Cuong Tran Chi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cuong C Tran, PhD

Role: STUDY_DIRECTOR

Can Tho Stroke International Services General Hospital

Locations

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Can Tho SIS Hospital

Can Tho, , Vietnam

Site Status

Countries

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Vietnam

References

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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.

Reference Type BACKGROUND
PMID: 34338742 (View on PubMed)

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.

Reference Type RESULT
PMID: 35396333 (View on PubMed)

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.

Reference Type RESULT
PMID: 31296523 (View on PubMed)

Other Identifiers

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CanTho SIS Hospital

Identifier Type: -

Identifier Source: org_study_id