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

Can Tho Stroke International Services Hospital

Status: Invitation-only

Conditions: Acute Ischemic Stroke

Treatments: Procedure: Standard workflow; Procedure: One-stop

Study type: Interventional

Funder types: Other

Identifiers

NCT05644938

CanTho SIS Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Standard workflow (SW)

Active Comparator group

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

Treatment:

Procedure: Standard workflow

One-stop (OS)

Experimental group

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.

Treatment:

Procedure: One-stop