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Multimodal Neuroimaging in the Selection of Acute Ischemic Stroke (AIS) Patients to Endovascular Treatment (EVT)

NCT03745391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2022-07-01

No results posted yet for this study

Summary

To study the feasibility and usefulness of multimodal MR compared to multimodal CT to select patients with acute ischemic stroke and favorable clinical outcome after mechanical thrombectomy. The specific objectives are to compare (1) the door-picture time and door-groin puncture time, (2) the rate of patients with acute stroke selected for endovascular treatment and (3) the safety and clinical response after thrombectomy between the two groups selected according to the imaging modality.

Methodology: Single-center, randomized 1:1 and stratified by age and NIHSS study of consecutive patients with suspected acute ischemic stroke. Occlusion site, ischemic volume (core) and perfusion volume will be studied by an automated perfusion system (RAPID software) in both neuroimaging groups. Mechanical thrombectomy criteria will be basically based on the presence of a Large Vessel Occlusion (LVO) and a volume of core lower than 70cc in the Cerebral Blood Flow (CBF) or Diffusion Weighted Image (DWI) sequences. Modified Rankin scale at 90 days and the rate of intracranial hemorrhage and mortality will be considered as variables of response.

Conditions

Interventions

DIAGNOSTIC_TEST

MULTIMODAL MAGNETIC RESONANCE (Multimodal MR)

After randomization, a MULTIMODAL MR will be performed to select treatment patient

DIAGNOSTIC_TEST

MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT)

After randomization, a MULTIMODAL CT will be performed to select treatment patient

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Meritxell Gomis, MD PhD · Germans Trias i Pujol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2021-06-15
Completion
2021-10-15

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745391 on ClinicalTrials.gov