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Completed

NCT Number: NCT03745391

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

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.

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Key information

Conditions

Ischemic Stroke Arterial Occlusion Arterial Occlusive Diseases Brain Diseases CTS Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Magnetic Resonance Imaging Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meritxell Gomis Cortina

Badalona, Barcelona, 08917, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

MULTIMODAL MAGNETIC RESONANCE (Multimodal MR)

Diagnostic Test

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

MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT)

Diagnostic Test

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

Primary outcomes

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

    Time frame: 90 days

    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.

Secondary outcomes

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

    Time frame: 90 days

    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.

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

    Time frame: 24-36 hours after stroke

    To compare the rate of symptomatic intracranial haemorrhage

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

    Time frame: 7-90 days after stroke

    To compare mortality at 7 days and 90 days

  4. 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

    Time frame: At 24 hours after stroke

    To compare vomiting during the acquisition technique time

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

    Time frame: During hospitalization after stroke (approximately 7 days)

    To compare the rate of in-hospital pneumonia

  6. Indication of EVT in each technique

    Time frame: Through study completion, approximately 1 year

    Rate of ischemic stroke patients selected for endovascular treatment by each technique

  7. Feasibility of multimodal neuroimaging to select patients for EVT

    Time frame: Through study completion, approximately 1 year

    Door-picture time and door-groin puncture time in each technique and movement artifacts

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study title

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

Acronym: IMAGECAT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2018
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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