Biomarkers to Predict Hemorrhage and Outcomes After Endov... | NCT03915834

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

NCT03915834

Sponsor

Capital Medical University

Status

Unknown status

Last Update Posted

Apr 16, 2019Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Acute Ischemic Stroke

Interventions

Endovascular treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 16, 2019Estimated

Primary Completion Date

Oct 31, 2019Estimated

Completion Date

Jan 31, 2020Estimated

First Submitted Date

Mar 18, 2019

First Submission Date that Met QC Criteria

Apr 14, 2019

First Posted Date

Apr 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
endovascular treatment group			Device: Endovascular treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endovascular treatment	Device	Mechanical thrombectomy and/or Aspiration	endovascular treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemorrhagic transformation	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.	24 to 72 hours

Secondary Outcomes

Measure	Description	Time Frame
Modified Rankin scale	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]).	90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

be 18 or older;
have a clinical diagnosis of acute ischemic stroke
a score of 6 or more points on the NIHSS(the National Institutes of Health Stroke Scale);
be scheduled to undergo intraarterial (IA) therapy for acute hemispheric stroke;
patients eligible for IV alteplase should receive IV alteplase;
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;
begin intra-arterial therapy within 24 hours of symptom onset;
have provided informed consent.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Acute ischemic stroke patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuan Wu Hospital，Capital Medical University		Beijing	Beijing Municipality	100069	China
Beijing Luhe Hospital, Capital Medical University

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D002543	Cerebral Hemorrhage

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

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Browse Branches

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