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Recruiting NCT06061185

Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke

Observational Acute Hemorrhagic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal CT.
Who it may be relevant to
Registry conditions: Acute Hemorrhagic Stroke. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke (MCTAHS)

Overview

Acute hemorrhagic stroke is a series of neurosurgical diseases characterized by bleeding with high morbidity and mortality. It accounts for about 20% of all strokes worldwide and mainly includes subtypes such as intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH). Multimodal computed tomography including non-contrast computed tomography, computed tomography angiography and computed tomography perfusion, is of great important in understanding pathophysiological changes, evaluating prognosis and guiding interventions in these diseases.

Detailed description

Study overview: The data of the population in the MACTAHS study will be prospectively collected. The CT strategies for acute hemorrhagic stroke are mainly three categories: non-contrast computed tomography, computed tomography angiography and computed tomography perfusion. Each participants will be followed at least until 1 year after discharge. Finally, investigators will clarify the prognostic value of multimodal CT for patients with acute hemorrhagic stroke.

Sample size: About 10000 patients will be enrolled in this study. All the population will be expected to undergo non-contrast computed tomography, computed tomography angiography and computed tomography perfusion.

Study endpoints: Neurological functional outcomes, delayed ischemia and infarction, recurrent bleeding, cognition and emotional dysfunction, systemic in-hospital systemic complications, rehabilitation and recovery status will be evaluated and follow-up would be completed.

Interventions

  • Device Multimodal CT
    Non-contrast computed tomography, computed tomography angiography and computed tomography perfusion

Primary outcome measures

  • modified Rankin Scale (mRS) [Time frame: At 3/6/12 months after onset]
Secondary outcome measures (12)
  • Mortality rate [Time frame: At 12 months after onset]
  • Total time spent on the intensive care unit (ICU)/stroke unit [Time frame: After treatment (max 60 days)]
  • Non-neurological systemic complications [Time frame: After onset (max 60 days)]
  • Delayed infarction [Time frame: After onset (max 30 days)]
  • Delayed ischemia [Time frame: After onset (max 30 days)]
  • Hematoma expansion in intracerebral hemorrhage [Time frame: 24-48 hours from symptom onset]
  • Recurrence of intracerebral hemorrhage [Time frame: 90 days from symptom onset]
  • Rebleeding of subarachnoid hemorrhage [Time frame: After onset (max 7 days)]
  • Montreal Cognitive Assessment Scale (MoCA) [Time frame: At 3/6/12 months after onset]
  • Mini-mental State Examination (MMSE) [Time frame: At 3/6/12 months after onset]
  • Self-Rating Anxiety Scale (SAS) [Time frame: At 3/6/12 months after onset]
  • Self-Rating Depression Scale (SDS) [Time frame: At 3/6/12 months after onset]

Eligibility criteria

Inclusion criteria

  • age ≥ 18, ≤ 85 years;
  • presence with hemorrhagic stroke

Exclusion criteria

  • with a history of previous history of ischemic/hemorrhagic stroke;
  • admission to the emergency department more than a week after symptom onset;
  • serious medical history or existing comorbidities;
  • physical disability due to previous diseases;
  • prior treatment such as external ventricular drainage, digital subtraction angiography and lumbar puncture in other institution;
  • poor original image quality;
  • incomplete follow-up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT06061185 · KY 2024-007-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗