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

NCT ID: NCT03915834

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-16

Study Completion Date

2020-01-31

Brief Summary

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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

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Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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endovascular treatment group

Endovascular treatment

Intervention Type DEVICE

Mechanical thrombectomy and/or Aspiration

Interventions

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Endovascular treatment

Mechanical thrombectomy and/or Aspiration

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ji Xunming,MD,PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xuan Wu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Beijing Luhe Hospital, Capital Medical University

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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2018-033

Identifier Type: -

Identifier Source: org_study_id

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