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

NCT05644938 | Unknown DMC

• 1 other identifier: CanTho SIS Hospital
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; angiosuite; reperfusion times; One-stop

Outcome Measures

Primary Outcomes (2)

• 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..

  1 day (During intrahospital)

• 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).

  3 months after procedure

Study Arms (2)

Standard workflow (SW)

ACTIVE COMPARATOR

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

One-stop (OS)

EXPERIMENTAL

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

Standard workflow 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.

Also known as: SW

Standard workflow (SW)

One-stop 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.

Also known as: OS

One-stop (OS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can Tho Stroke International Services Hospital: lead
• Siemens Healthineers AG: collaborator

Study Sites (1)

Can Tho SIS Hospital

Can Tho, 900000, Vietnam

Location

Related Publications (3)

• 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.

  PMID: 34338742 BACKGROUND

• 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.

  PMID: 35396333 RESULT

• 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.

  PMID: 31296523 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cuong C Tran, PhD

  Can Tho Stroke International Services General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are only blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 9, 2022
• Study Start: February 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)