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

NCT03915834 | Unknown DMC

• 1 other identifier: 2018-033
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Ischemic Stroke

Keywords

Biomarker; Mechanical thrombectomy; Intracerebral Hemorrhage; Acute Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Modified Rankin scale

  90 days

Study Arms (1)

endovascular treatment group

Device: Endovascular treatment

Interventions

Endovascular treatment DEVICE

Mechanical thrombectomy and/or Aspiration

endovascular treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Acute ischemic stroke patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (2)

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

Beijing Luhe Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: April 16, 2019
• Study Start: April 16, 2019
• Primary Completion: October 31, 2019
• Study Completion: January 31, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

CN (2)