Biomarkers to Predict Hemorrhage and Outcomes After Endovascular Treatment in Patients With Acute Large Vessel Occlusion
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|ClinicalTrials.gov Identifier: NCT03915834|
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
The main aim of the biomarkers to predict Hemorrhagic transformation(HT) after endovascular treatment in Acute Ischemic Stroke Patients.
The study has three main parts. During the first part, the investigators propose to conduct an enrollment of patients after thrombectomy in acute Ischemic Stroke and healthy controls. Serum biomarkers levels were analyzed (before and after) endovascular treatment patients and controls respectively.
During the second part, HT was evaluated and classified on cranial computed tomography and/or MRI post- treatment and was considered as symptomatic HT (sHT) if associated with neurological deterioration.
During the third part, the investigators aim to demonstrate the level of biomarkers can significant predict HT and outcomes in stroke patients undergoing revascularization.
|Condition or disease||Intervention/treatment|
|Acute Ischemic Stroke||Device: Endovascular treatment|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Biomarkers to Predict Hemorrhage and Outcomes After Endovascular Treatment in Patients With Acute Large Vessel Occlusion|
|Estimated Study Start Date :||April 16, 2019|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||January 31, 2020|
|endovascular treatment group||
Device: Endovascular treatment
Mechanical thrombectomy and/or Aspiration
- Hemorrhagic transformation [ Time Frame: 24 to 72 hours ]Hemorrhagic transformation was diagnosed by Computed tomographic scans usually performed 24 to 72 hours after the procedure.Symptomatic intracranial hemorrhage was defined as neurologic deterioration (an increase of 4 or more points in the score on the NIHSS) and evidence of intracranial hemorrhage on imaging studies.
- Modified Rankin scale [ Time Frame: 90 days ]this scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death).scores of the modified Rankin scale at 2 years (0 or 1 [excel- lent outcome], 0 to 2 [good outcome, indicating functional independence], and 0 to 3 [favorable outcome]).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915834
|Xuan Wu Hospital，Capital Medical University|
|Beijing, Beijing, China, 100069|
|Beijing Luhe Hospital, Capital Medical University|