Clinical trial NCT06061185: Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke
Official title: Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke (MCTAHS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Hemorrhagic Stroke
Keywords: Acute Hemorrhagic Stroke
Multimodal CT
Prognosis
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
name: Zhangzhou Municipal Hospital of Fujian Province
name: The First Affiliated Hospital of Shanxi Medical University
name: Santai County People&amp;#39;s Hospital
name: Jiujiang No.1 People&amp;#39;s Hospital
name: Qin Zhou NO.1 People&#39;s Hospital
name: Sichuan Academy of Medical Sciences
name: Linyi People's Hospital
First posted: 2023-09-29
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presented to the emergency department with hemorrhagic stroke.

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.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18, ≤ 85 years;
2. presence with hemorrhagic stroke

Exclusion Criteria:

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

Primary outcomes:
measure: modified Rankin Scale (mRS)
timeFrame: At 3/6/12 months after onset
Secondary outcomes:
measure: Mortality rate
timeFrame: At 12 months after onset
measure: Total time spent on the intensive care unit (ICU)/stroke unit
timeFrame: After treatment (max 60 days)
measure: Non-neurological systemic complications
timeFrame: After onset (max 60 days)
measure: Delayed infarction
timeFrame: After onset (max 30 days)
measure: Delayed ischemia
timeFrame: After onset (max 30 days)
measure: Hematoma expansion in intracerebral hemorrhage
timeFrame: 24-48 hours from symptom onset
measure: Recurrence of intracerebral hemorrhage
timeFrame: 90 days from symptom onset
measure: Rebleeding of subarachnoid hemorrhage
timeFrame: After onset (max 7 days)
measure: Montreal Cognitive Assessment Scale (MoCA)
timeFrame: At 3/6/12 months after onset
measure: Mini-mental State Examination (MMSE)
timeFrame: At 3/6/12 months after onset
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: At 3/6/12 months after onset
measure: Self-Rating Depression Scale (SDS)
timeFrame: At 3/6/12 months after onset
measure: Hamilton Rating Scale for Anxiety
timeFrame: At 3/6/12 months after onset
measure: Hamilton Rating Scale for Depression
timeFrame: At 3/6/12 months after onset
measure: Fatigue
timeFrame: At 12 months after onset
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Tu Li, M.D.
role: STUDY_CHAIR
affiliation: Beijing Tiantan Hospital
name: Zhenshan Song, M.D.
role: STUDY_CHAIR
affiliation: Beijing Tiantan Hospital
name: Runting Li, M.D.
role: STUDY_CHAIR
References: