Multi-center Study of Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke (MMCTAHS)

Multi-center Study of Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke (MMCTAHS)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Hemorrhagic Stroke
• Intervention / Treatment: Device: Multimodal CT

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Xiaolin Chen, M.D.; Phone Number: 13810624845; Email: chenxiaolin@bjtth.org

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Xiaolin Chen, M.D.; Phone Number: 13810624845; Email: chenxiaolin@bjtth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients presented to the emergency department with hemorrhagic stroke.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Testing populations; All patients with the possibility of acute hemorrhagic stroke and suitable for multimodal CT examination	Device: Multimodal CT; Non-contrast computed tomography, computed tomography angiography and computed tomography perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin Scale (mRS)	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	At 3/6/12 months after onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Mortality rate as measured by death of a participant (binary outcome (yes/no)	At 12 months after onset
Total time spent on the intensive care unit (ICU)/stroke unit	The total time spent on the intensive care unit (ICU)/stroke unit as a continuous variable from the first admission to the ICU/stroke unit to discharge from ICU/stroke unit	After treatment (max 60 days)
Non-neurological systemic complications	This category of diseases mainly refers to a series of non-neurological systemic complication such as electrolyte alterations, cardiovascular complications, pneumonia, gastrointestinal alterations, coagulation disorders and so on	After onset (max 60 days)
Delayed infarction	Delayed onset of any type of infarction detected by NCCT/MRI/CTP after surgical treatment or during conservative treatment	After onset (max 30 days)
Delayed ischemia	Delayed onset of various types of ischemia detected by PWI/CTP after surgical treatment or during conservative treatment, as well as a short period decline of cognitive and neurological status	After onset (max 30 days)
Hematoma expansion in intracerebral hemorrhage	non-contrast CT scan: the enlargement of hematoma ≥ 6ml	24-48 hours from symptom onset
Recurrence of intracerebral hemorrhage	non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary bleeding	90 days from symptom onset
Rebleeding of subarachnoid hemorrhage	Rebleeding Hemorrhage in subarachnoid space proven on CT/MR scan	After onset (max 7 days)
Montreal Cognitive Assessment Scale (MoCA)	It included 11 tests in eight cognitive areas: attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, computation, and orientation. Total score 30, ≥26 normal	At 3/6/12 months after onset
Mini-mental State Examination (MMSE)	The scale includes the following seven aspects: time orientation, place orientation, immediate memory, attention and computation, delayed memory, language, visual space. A total of 30 questions, each correct answer is 1 point, the answer is wrong or do not know 0 points, the scale total range of 0-30 points. Test scores are closely related to literacy level, and the normal cut-off values are: illiterate >17 points, primary >20 points, junior high school and above >24 points.	At 3/6/12 months after onset
Self-Rating Anxiety Scale (SAS)	The scale consists of 20 items with 4 marks for each item. The scores of each of the 20 items are added together, and then multiplied by 1.25 to get the integer part. The total score of anxiety less than 50 points is normal; 50-60 is mild, 61-70 is moderate, and over 70 is severe anxiety.	At 3/6/12 months after onset
Self-Rating Depression Scale (SDS)	The scale consists of 20 items with 4 marks for each item. The scores of each of the 20 items are added together, and then multiplied by 1.25 to get the integer part. The cut-off value of the SDS standard score is 53 points, of which 53-62 is classified as mild depression, 63-72 is classified as moderate depression, and 73 or more is severe depression.	At 3/6/12 months after onset
Hamilton Rating Scale for Anxiety	Anxiety will be assessed using the Hamilton Rating Scale for Anxiety. The Hamilton Anxiety Rating Scale measures the severity of anxiety through looking at both psychic and somatic anxiety. Each item is scored on a scale of 0 to 4, with a total range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	At 3/6/12 months after onset
Hamilton Rating Scale for Depression	Depression will be assessed using the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 21 item questionnaire to treat and diagnosis severe depression. Examining a different symptom or aspect of depression such as mood, guilty feelings, suicidal ideation, etc.. The first 17 questions are used for scoring. A total score is tallied from 1-17 and if the score totals: 0-7 normal, 8-13 mild depression, 14-18 moderate depression, 19-22 severe depression, >23 very severe depression.	At 3/6/12 months after onset
Fatigue	Fatigue will be assessed using the Fatigue Severity Scale. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle in patients exhibiting depression. The scale is designed to differentiate fatigue from clinical depression since they share similar symptoms. Scoring is done by calculating the average response to the question and people with depression typically score about 4.5 whereas those with fatigue average about 6.5.	At 12 months after onset

Collaborators and Investigators

• Sponsor: Xiaolin Chen, MD
• Collaborators: Peking University International Hospital; The First Affiliated Hospital of Shanxi Medical University; Zhangzhou Municipal Hospital of Fujian Province
• Investigators: Study Chair: Tu Li, M.D., Beijing Tiantan Hospital; Study Chair: Zhenshan Song, M.D., Beijing Tiantan Hospital; Study Chair: Runting Li, M.D., Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): April 1, 2032

Study Registration Dates

• First Submitted: September 10, 2023
• First Submitted That Met QC Criteria: September 24, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Prognosis; Multimodal CT; Acute Hemorrhagic Stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: KY 2021-008-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No