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

NCT03745391 | Completed

• 1 other identifier: Hospital Germans Trias i Pujol
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

Brief 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

Ischemic Stroke; Arterial Occlusion; CTS; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• To evaluate long-term clinical outcome in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique

  Modified Rankin Scale (mRS) ordinal distribution in each group. The mRS measures the patient functional status. It range from 0 to 6, and the values are (0, 1, 2, 3, 4, 5 and 6). The 0 value indicate a patient completely functional independent and without neurological deficit and 6 value indicate death. The value 1 indicate a minor neurological deficit but the patient is fully independent, the value 2 indicate that the patient do not perform all his activities (like work) but is fully independent for the daily activities so can live alone without assistance, value 3 indicates a patient partially dependent taht can not live alone during more than a week, value 4 indicates a patient totally dependent in a wheelchair but able to be some hours without assistance, and value 5 indicates a patient totally dependent in bed.

  90 days

Secondary Outcomes (7)

• To evaluate long-term good clinical outcome in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique

  90 days

• To evaluate the rate of symptomatic intracerebral haemorrhage in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique

  24-36 hours after stroke

• To evaluate mortality in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique

  7-90 days after stroke

• To evaluate the presence of vomiting during the acquisition technique in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique

  At 24 hours after stroke

• To evaluate the presence of in-hospital pneumonia in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique

  During hospitalization after stroke (approximately 7 days)

Study Arms (2)

MULTIMODAL MAGNETIC RESONANCE (MR)

ACTIVE COMPARATOR

Diagnostic test: Multimodal Neuroimaging Test: MR The group of patients with clinical suspicion of acute stroke and that fulfill the inclusion/exclusion criteria for the study that after randomization be assigned to Multimodal MR, will be directedly transferred to MR. It will be performed a multimodal MR taking into account that after discard an intracerebral haemorrhage and confirm an ischemic lesion if the patient fulfill criteria to receive intravenous alteplase, the test will be paused just to administer the treatment and immediately put again into the machine to complete the MR images. With all the information vascular neurologist will be decide if it is necessary administer endovascular treatment.

Diagnostic Test: MULTIMODAL MAGNETIC RESONANCE (Multimodal MR)

MULTIMODAL COMPUTED TOMOGRAPHY (CT)

ACTIVE COMPARATOR

Diagnostic test: Multimodal Neuroimaging Test: CT The group of patients with clinical suspicion of acute stroke and that fulfill the inclusion/exclusion criteria for the study that after randomization is assigned to Multimodal CT, will be directedly transferred to CT. If the patient fulfill criteria to receive intravenous alteplase after discard an intracerebral haemorrhage the CT will be paused to administer the treatment and immediately will continue with the test. At the end of the test the vascular neurologist will decide if it is necessary administer endovascular treatment.

Diagnostic Test: MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT)

Interventions

MULTIMODAL MAGNETIC RESONANCE (Multimodal MR) DIAGNOSTIC_TEST

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

MULTIMODAL MAGNETIC RESONANCE (MR)

MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT) DIAGNOSTIC_TEST

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

MULTIMODAL COMPUTED TOMOGRAPHY (CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Without previous functional dependency evaluated by modified Rankin Score ≤2
• Regarding stroke severity (NIHSS≥ 6)
• Time from symptoms onset \<24 hours

You may not qualify if:

• Clinical suspicion of vertebrobasilar occlusion (brainstem symptoms)
• MR contraindication or lack of concomitant availability of one or both neuroimaging techniques
• Severe kidney failure

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Meritxell Gomis Cortina

Badalona, Barcelona, 08917, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Meritxell Gomis, MD PhD

  Germans Trias i Pujol Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded neurologist investigator (M. Gomis) will perform the clinical assesment of included patients at 90 days in outpatient clinics
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology

Model Details: Patients will be included consecutively and randomized (1:1) to Multimodal MR or Multimodal CT stratifying by age (\<70, ≥70), stroke severity (NIHSS\<18, ≥18) and time from onset to hospital (\<8 hours, ≥8 hours)

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: November 19, 2018
• Study Start: November 13, 2018
• Primary Completion: June 15, 2021
• Study Completion: October 15, 2021
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

ES (1)