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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915834
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, 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.


Condition or disease Intervention/treatment
Acute Ischemic Stroke Device: Endovascular treatment

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
endovascular treatment group Device: Endovascular treatment
Mechanical thrombectomy and/or Aspiration




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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]).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Acute ischemic stroke patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915834


Locations
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China, Beijing
Xuan Wu Hospital,Capital Medical University
Beijing, Beijing, China, 100069
China
Beijing Luhe Hospital, Capital Medical University
Beijing, China
Sponsors and Collaborators
Capital Medical University
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Responsible Party: Ji Xunming,MD,PhD, Principal Investigator, Capital Medical University
ClinicalTrials.gov Identifier: NCT03915834    
Other Study ID Numbers: 2018-033
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji Xunming,MD,PhD, Capital Medical University:
Biomarker
Mechanical thrombectomy
Intracerebral Hemorrhage
Acute Ischemic stroke
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes