Biomarkers to Predict Hemorrhage and Outcomes After Endovascular Treatment in Patients With Acute Large Vessel Occlusion

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Endovascular treatment

• Registration Number: NCT03915834
• Lead Sponsor: Capital Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-14
• Last Update Submitted: 2019-04-14
• Study Start: 2019-04-16
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16
• Primary Completion: 2019-10-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. be 18 or older;
2. have a clinical diagnosis of acute ischemic stroke
3. a score of 6 or more points on the NIHSS(the National Institutes of Health Stroke Scale);
4. be scheduled to undergo intraarterial (IA) therapy for acute hemispheric stroke;
5. patients eligible for IV alteplase should receive IV alteplase;
6. Intracranial arterial occlusion of the distal intracranial carotid artery, middle (M1/M2) ,anterior (A1/A2) cerebral artery,vertebral artery,basilar artery or posterior cerebral artery,demonstrated with CTA, MRA or DSA;
7. begin intra-arterial therapy within 24 hours of symptom onset;
8. have provided informed consent.

Exclusion Criteria

1. have any pre-existing illness resulting in a modified Rankin Scale Score of 3 or higher prior to the qualifying stroke;
2. patients with known infectious, inflammatory, or neoplastic diseases at the time of treatment and non-availability of blood samples;
3. are pregnant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
endovascular treatment group	Endovascular treatment	-

Primary Outcome Measures

Name	Time	Method
Hemorrhagic transformation	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.

Secondary Outcome Measures

Name	Time	Method
Modified Rankin scale	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 \[favorable outcome\]).

Trial Locations

Locations (2)

Xuan Wu Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Luhe Hospital, Capital Medical University; 🇨🇳 Beijing, China