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

Ischemic Stroke Clinical Trial

— IMAGECAT  

Official title:

IMAGECAT Study: Multimodal Neuroimaging of Choice in the Selection of Patients With Acute Stroke and Favorable Clinical Response to Endovascular Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745391
• Other study ID #: Hospital Germans Trias i Pujol
• Status: Completed
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: October 15, 2021

Study information

• Verified date: June 2022
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: October 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusion
• CTS
• Ischemia
• Ischemic Stroke
• Magnetic Resonance Imaging
• Stroke

Intervention

Diagnostic Test:
• MULTIMODAL MAGNETIC RESONANCE (Multimodal MR)
After randomization, a MULTIMODAL MR will be performed to select treatment patient
• MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT)
After randomization, a MULTIMODAL CT will be performed to select treatment patient

Locations

Country	Name	City	State
Spain	Meritxell Gomis Cortina	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate long-term good clinical outcome in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique	Modified Rankin Scale (mRS<3) 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	To evaluate the rate of symptomatic intracerebral haemorrhage in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique	To compare the rate of symptomatic intracranial haemorrhage	24-36 hours after stroke
Secondary	To evaluate mortality in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique	To compare mortality at 7 days and 90 days	7-90 days after stroke
Secondary	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	To compare vomiting during the acquisition technique time	At 24 hours after stroke
Secondary	To evaluate the presence of in-hospital pneumonia in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique	To compare the rate of in-hospital pneumonia	During hospitalization after stroke (approximately 7 days)
Secondary	Indication of EVT in each technique	Rate of ischemic stroke patients selected for endovascular treatment by each technique	Through study completion, approximately 1 year
Secondary	Feasibility of multimodal neuroimaging to select patients for EVT	Door-picture time and door-groin puncture time in each technique and movement artifacts	Through study completion, approximately 1 year