Clinical trial NCT03745391: Multimodal Neuroimaging in the Selection of Acute Ischemic Stroke (AIS) Patients to Endovascular Treatment (EVT)
Official title: IMAGECAT Study: Multimodal Neuroimaging of Choice in the Selection of Patients With Acute Stroke and Favorable Clinical Response to Endovascular Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Arterial Occlusion
CTS
Magnetic Resonance Imaging
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: DIAGNOSTIC

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.

Detailed description: In acute ischemic stroke, arterial occlusion lead to a brain ischemia that will progress to brain death of the ischemic area if the clot is not rapidly removed. Advanced neuroimaging can help us to distinguish between the irreversible injury brain parenchyma or core and the potential reversible ischemic tissue or penumbra. Multimodal neuroimaging techniques (MR and CT) have been developed in order to distinguish between core and penumbra areas and have been used to select patients in most of the last randomized clinical trials that have demonstrated the benefit of endovascular treatment. There is no agreement about which multimodal technique offers a better information to select patients for endovascular treatment.

The main aim is 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: Primary: to confirm no differences in long-term clinical outcome in patients with acute ischemic stroke and in those treated with endovascular therapy selected by multimodal CT or MR; and Secondary: (1) compare the feasibility of both techniques in this setting, (2) the door-picture time and door-groin puncture time of both techniques, (3) the safety of both techniques (sICH and in-hospital pneumonia) Methodology: Single-center, randomized (1:1) and stratified by age and NIHSS study of consecutive patients with 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 an intracranial LVO occlusion and a volume of core lower than 70cc in the CBF or DWI sequences. Modified Rankin scale at 90 days and the rate of intracranial hemorrhage and mortality will be considered as variables of response.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: To evaluate long-term clinical outcome in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
timeFrame: 90 days
Secondary outcomes:
measure: To evaluate long-term good clinical outcome in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
timeFrame: 90 days
measure: To evaluate the rate of symptomatic intracerebral haemorrhage in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
timeFrame: 24-36 hours after stroke
measure: To evaluate mortality in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
timeFrame: 7-90 days after stroke
measure: 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
timeFrame: At 24 hours after stroke
measure: To evaluate the presence of in-hospital pneumonia in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
timeFrame: During hospitalization after stroke (approximately 7 days)
measure: Indication of EVT in each technique
timeFrame: Through study completion, approximately 1 year
measure: Feasibility of multimodal neuroimaging to select patients for EVT
timeFrame: Through study completion, approximately 1 year
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Meritxell Gomis Cortina
state: Barcelona
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Meritxell Gomis, MD PhD
role: STUDY_CHAIR
References: