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Status unknownNCT05644938ORETOMUpdated Dec 9, 2022

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

An interventional study of Standard workflow and One-stop in Acute Ischemic Stroke, sponsored by Can Tho Stroke International Services Hospital. Status unknown at 1 site in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-09.

Sponsored by Can Tho Stroke International Services Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Ischemic Stroke

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Keywords

  • acute ischemic stroke
  • angiosuite
  • reperfusion times
  • One-stop
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 50 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Can Tho Stroke International Services Hospital is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    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

    Procedure: Standard workflow

  • Experimental
    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.

    Procedure: One-stop

Interventions

  • ProcedureStandard 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.

    Also known as: SW

  • ProcedureOne-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.

    Also known as: OS

06

What researchers measure

Primary outcomes

  1. Door-to-reperfusion times

    Door-to-reperfusion times was defined as the time from admission in emergency department to recanalization in case of large vessel occlusion at the angiosuite..

    Time frame: 1 day (During intrahospital)

  2. Functional 3 - month outcome rate

    Functional 3 - month outcome rate was accessed by modified Rankin Score (mRS), which comprised of included good (mRS 0 - ≤ 2) and fair (mRS 3).

    Time frame: 3 months after procedure

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Study locations

1 site
  • Can Tho SIS Hospital
    Cần Thơ, 900000, Vietnam
08

References and documents

Publications

  • 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. PubMed 34338742 ↗
  • 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. PubMed 35396333 ↗
  • 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. PubMed 31296523 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05644938
Lead sponsor
Can Tho Stroke International Services Hospital
Collaborators
Siemens Healthineers AG
Responsible party
Dr. Cuong Tran Chi (Principal Investigator, Can Tho Stroke International Services Hospital) — Principal investigator
First posted
Dec 9, 2022
Start date
Feb 1, 2023 (estimated)
Primary completion
Dec 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Dec 9, 2022

Study contacts

Cuong C Tran, PhD
study director · Can Tho Stroke International Services General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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