Acute Ischemic Stroke Clinical Trial
— PHASEOfficial title:
Research of the Prediction of Hemorrhage Transformation and Clinical Outcome by Cerebral Autoregulation After Endovascular Thrombectomy in Acute Ischemic Stroke Patients Caused by Middle Cerebral Artery or Internal Carotid Artery Occlusion.
Verified date | April 2023 |
Source | Xuanwu Hospital, Beijing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcome. Patients: patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT. dCA Examination: dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT. The objectives of the study were as follows: The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed. So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes.
Status | Enrolling by invitation |
Enrollment | 300 |
Est. completion date | March 1, 2026 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - (i) age =18 years; (ii) complete recanalization of the affected MCA (thrombolysis in cerebral infarction grade 2b or 3); and (iii) sufficient temporal windows to obtain ?ow signals for the MCA. Exclusion Criteria: - (i) inability to perform dCA after EVT due to restlessness; (ii) re-occlusion of the culprit MCA after EVT; and (iii) other conditions such as low cerebral blood ?ow caused by severe heart disease. |
Country | Name | City | State |
---|---|---|---|
China | Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
China,
Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11. — View Citation
Tian G, Ji Z, Huang K, Lin Z, Pan S, Wu Y. Dynamic cerebral autoregulation is an independent outcome predictor of acute ischemic stroke after endovascular therapy. BMC Neurol. 2020 May 15;20(1):189. doi: 10.1186/s12883-020-01737-w. — View Citation
Zhao W, Liu R, Yu W, Wu L, Wu C, Li C, Li S, Chen J, Song H, Hua Y, Ma Q, Ji X. Elevated pulsatility index is associated with poor functional outcome in stroke patients treated with thrombectomy: A retrospective cohort study. CNS Neurosci Ther. 2022 Oct;2 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The occurrence of hemorrhage transformation | The AIS patients have hemorrhage transformation detected by head computed tomography scans within 7 days after EVT | 7 days | |
Primary | Patients without hemorrhage transformation | The AIS patients do not have hemorrhage transformation detected by head computed tomography scans within 7 days after EVT | 7 days | |
Primary | The occurrence of unfavorable outcome | The modified Rankin Scale (mRS) score was 3-6 of AIS patients with EVT after 3 months. | 3 months | |
Primary | The occurrence of favorable outcome | The modified Rankin Scale (mRS) score =2 of AIS patients with EVT after 3 months. | 3 months | |
Secondary | The occurrence of long-term unfavorable outcome | The modified Rankin Scale (mRS) score was 3-6 of AIS patients with EVT after 1 year. | 1 year | |
Secondary | The occurrence of long-term favorable outcome | The modified Rankin Scale (mRS) score =2 of AIS patients with EVT after 1 year. | 1 year |
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