Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTianjin Huanhu Hospital
About this trial
The objective of this study is to create a comprehensive, real-world, multi-center observational registry of consecutive patients admitted to hospitals with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO), who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
Age ≥ 18;
Ischemic stroke confirmed by head CT or MRI;
Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);
Disqualifiers
None
Trial population
All acute ischemic stroke patients with large vessel occlusion.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endovascular Therapy
Procedure/SurgeryEndovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices.
Treatment groups
5,000 Participants
are divided into 2 treatment groupsGroup A: Endovascular therapy1 intervention
Group B: Best medical management0 interventions
Trial outcomes
Primary outcomes
1
Modified ranking scale (mRS) at 90 days
A 0-6 scale running from perfect health without symptoms to death.
Time frame
90 days2
Mortality within 90 days
mortality of any causes.
Time frame
90 daysSecondary outcomes
1
National Institutes of Health Stroke Scale (NIHSS) scores at 90 days
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Time frame
90 days2
Occurrence of periprocedural complications
Periprocedural complications include any intracranial hemorrhage, cerebral edema, brain herniation and pneumonia.
Time frame
14 days postoperatively3
ASPECT (Alberta Stroke Program Early CT score)
ASPECTS is a 10-point quantitative topographic CT scan score used in patients with middle cerebral artery (MCA) stroke.
Time frame
Day 04
EuroQol five dimensions questionnaire (EQ-5D)
The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov