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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03915834
Enrollment
300
Registered
2019-04-16
Start date
2019-04-16
Completion date
2020-01-31
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

Biomarker, Mechanical thrombectomy, Intracerebral Hemorrhage, Acute Ischemic stroke

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.

Interventions

DEVICEEndovascular treatment

Mechanical thrombectomy and/or Aspiration

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hemorrhagic transformation24 to 72 hoursHemorrhagic 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

MeasureTime frameDescription
Modified Rankin scale90 daysthis 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 \[favorable outcome\]).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026