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

Acute Ischemic Stroke Clinical Trial

— ORETOM  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05644938
• Other study ID #: CanTho SIS Hospital
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Can Tho Stroke International Services Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• 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.
• One-stop
The OS group transferred directly to ?at-detector computed tomography to consider recanalization by either intervention or recombinant Tissue Plasminogen Activator (rTPA) in the angiosuite.

Locations

Country	Name	City	State
Vietnam	Can Tho SIS Hospital	C?n Tho

Sponsors (2)

Lead Sponsor	Collaborator
Can Tho Stroke International Services Hospital	Siemens Healthineers AG

Country where clinical trial is conducted

Vietnam, 

References & Publications (3)

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. — View 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 imagin — View Citation

Requena M, Olivé-Gadea M, Muchada M, Hernández D, Rubiera M, Boned S, Piñana C, Deck M, García-Tornel Á, Díaz-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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