Multimodal Computed Tomography in Patients With 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 →
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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