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Status unknownNCT03915834Updated Apr 16, 2019

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

An observational study in Acute Ischemic Stroke, sponsored by Capital Medical University. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.

Sponsored by Capital Medical University · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Acute Ischemic Stroke

Keywords

  • Biomarker
  • Mechanical thrombectomy
  • Intracerebral Hemorrhage
  • Acute Ischemic stroke
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In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 300 is close to the median of 300 across 777 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Acute ischemic stroke patients

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • endovascular treatment group

    Device: Endovascular treatment

Interventions

  • DeviceEndovascular treatment

    Mechanical thrombectomy and/or Aspiration

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What researchers measure

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.

    Time frame: 24 to 72 hours

Secondary outcomes

  1. 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 \[favorable outcome\]).

    Time frame: 90 days

07

Study locations

2 sites
  • Xuan Wu Hospital,Capital Medical University
    Beijing, Beijing 100069, China
  • Beijing Luhe Hospital, Capital Medical University
    Beijing, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03915834
Lead sponsor
Capital Medical University
Responsible party
Ji Xunming,MD,PhD (Principal Investigator, Capital Medical University) — Principal investigator
First posted
Apr 16, 2019
Start date
Apr 16, 2019 (estimated)
Primary completion
Oct 31, 2019 (estimated)
Completion
Jan 31, 2020 (estimated)
Last update
Apr 16, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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