Acute Ischemic Stroke Clinical Trial
— TRACK-LVO LateOfficial title:
Triage of Patients Presenting Beyond 24 Hours From Last Known Well With Acute Ischemic Stroke Due to Large Vessel Occlusions (TRACK-LVO Late): a TRACK-LVO Registry-linked Cohort
Verified date | December 2023 |
Source | Tianjin Huanhu Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this study is to create a comprehensive, multi-center, TRACK-LVO registry-linked cohort of consecutive patients with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO) and presenting to each participating center beyond 24 hours from last known well, who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patient admitted from Jan. 1st 2018 to Jan. 1st 2028; - Presenting beyond 24 hours from last known well; - 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); - Patients receiving either endovascular therapy or best medical treatment. Exclusion Criteria: • Presence of any forms of cerebral hemorrhage on CT/MR at admission. |
Country | Name | City | State |
---|---|---|---|
China | Tianjin Huanhu Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Huanhu Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified ranking scale (mRS) at 90 days | A 0-6 scale running from perfect health without symptoms to death. | 90 days | |
Primary | symptomatic intracranial hemorrhage | any hemorrhagic transformation on subsequent imaging associated with a neurological decline of at least 4 points increase on the NIHSS score | 72 hours | |
Secondary | 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. | 1, 3, 5 (or discharge), 7 (or discharge) and 90 days | |
Secondary | Occurrence of periprocedural complications | Periprocedural complications include any intracranial hemorrhage, cerebral edema, brain herniation and pneumonia. | 72 hours | |
Secondary | 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. | 1 year |
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