Ischemic Stroke Clinical Trial
— IMAGECATOfficial title:
IMAGECAT Study: Multimodal Neuroimaging of Choice in the Selection of Patients With Acute Stroke and Favorable Clinical Response to Endovascular Treatment
Verified date | June 2022 |
Source | Germans Trias i Pujol Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Meritxell Gomis Cortina | Badalona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Germans Trias i Pujol Hospital |
Spain,
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 |
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