search
Back to results

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

Primary Purpose

Acute Ischemic Stroke

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Standard workflow
One-stop
Sponsored by
Can Tho Stroke International Services Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring acute ischemic stroke, angiosuite, reperfusion times, One-stop

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Can Tho SIS Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard workflow (SW)

One-stop (OS)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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..
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).

Secondary Outcome Measures

Full Information

First Posted
November 26, 2022
Last Updated
December 8, 2022
Sponsor
Can Tho Stroke International Services Hospital
Collaborators
Siemens Healthineers AG
search

1. Study Identification

Unique Protocol Identification Number
NCT05644938
Brief Title
Optimizing Door-to-reperfusion Times of One-stop Management in Acute Ischemic Stroke
Acronym
ORETOM
Official Title
Optimizing Door-to-reperfusion Times of One-stop Management in Acute Ischemic Stroke Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Can Tho Stroke International Services Hospital
Collaborators
Siemens Healthineers AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
acute ischemic stroke, angiosuite, reperfusion times, One-stop

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Masking Description
Patients are only blinded to the allocation.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard workflow (SW)
Arm Type
Active Comparator
Arm Description
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
Arm Title
One-stop (OS)
Arm Type
Experimental
Arm Description
Acute ischemic stroke caused by large vessel occlusion was diagnosed + Recanalization therapy by the flat-detector computed tomography in angiosuite at the same time.
Intervention Type
Procedure
Intervention Name(s)
Standard workflow
Other Intervention Name(s)
SW
Intervention Description
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
Intervention Name(s)
One-stop
Other Intervention Name(s)
OS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Door-to-reperfusion times
Description
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)
Title
Functional 3 - month outcome rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cuong C Tran, PhD
Organizational Affiliation
Can Tho Stroke International Services General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Can Tho SIS Hospital
City
Cần Thơ
ZIP/Postal Code
900000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34338742
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.
Results Reference
background
PubMed Identifier
35396333
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.
Results Reference
result
PubMed Identifier
31296523
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs