Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke (MCTAHS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Hemorrhagic Stroke
- Sponsor
- Xiaolin Chen, MD
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- modified Rankin Scale (mRS)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Xiaolin Chen, MD
Principal Investigator
Beijing Tiantan Hospital
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.
Outcomes
Primary Outcomes
modified Rankin Scale (mRS)
Time Frame: At 3/6/12 months after onset
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
Secondary Outcomes
- Fatigue(At 12 months after onset)
- Delayed infarction(After onset (max 30 days))
- Delayed ischemia(After onset (max 30 days))
- Self-Rating Anxiety Scale (SAS)(At 3/6/12 months after onset)
- Hamilton Rating Scale for Depression(At 3/6/12 months after onset)
- Non-neurological systemic complications(After onset (max 60 days))
- Hematoma expansion in intracerebral hemorrhage(24-48 hours from symptom onset)
- Montreal Cognitive Assessment Scale (MoCA)(At 3/6/12 months after onset)
- Mortality rate(At 12 months after onset)
- Total time spent on the intensive care unit (ICU)/stroke unit(After treatment (max 60 days))
- Recurrence of intracerebral hemorrhage(90 days from symptom onset)
- Rebleeding of subarachnoid hemorrhage(After onset (max 7 days))
- Mini-mental State Examination (MMSE)(At 3/6/12 months after onset)
- Self-Rating Depression Scale (SDS)(At 3/6/12 months after onset)
- Hamilton Rating Scale for Anxiety(At 3/6/12 months after onset)