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NCT Number: NCT06061185

Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Xiaolin Chen, M.D.

CONTACT

[email protected]

13810624845

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal CT

Device

Non-contrast computed tomography, computed tomography angiography and computed tomography perfusion

Primary outcomes

  1. 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

  1. Mortality rate

    Time frame: At 12 months after onset

    Mortality rate as measured by death of a participant (binary outcome (yes/no)

  2. Total time spent on the intensive care unit (ICU)/stroke unit

    Time frame: After treatment (max 60 days)

    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

  3. Non-neurological systemic complications

    Time frame: After onset (max 60 days)

    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

  4. Delayed infarction

    Time frame: After onset (max 30 days)

    Delayed onset of any type of infarction detected by NCCT/MRI/CTP after surgical treatment or during conservative treatment

  5. Delayed ischemia

    Time frame: After onset (max 30 days)

    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

  6. Hematoma expansion in intracerebral hemorrhage

    Time frame: 24-48 hours from symptom onset

    non-contrast CT scan: the enlargement of hematoma ≥ 6ml

  7. Recurrence of intracerebral hemorrhage

    Time frame: 90 days from symptom onset

    non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary bleeding

  8. Rebleeding of subarachnoid hemorrhage

    Time frame: After onset (max 7 days)

    Rebleeding Hemorrhage in subarachnoid space proven on CT/MR scan

  9. Montreal Cognitive Assessment Scale (MoCA)

    Time frame: At 3/6/12 months after onset

    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

  10. Mini-mental State Examination (MMSE)

    Time frame: At 3/6/12 months after onset

    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.

  11. Self-Rating Anxiety Scale (SAS)

    Time frame: At 3/6/12 months after onset

    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.

  12. Self-Rating Depression Scale (SDS)

    Time frame: At 3/6/12 months after onset

    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.

  13. Hamilton Rating Scale for Anxiety

    Time frame: At 3/6/12 months after onset

    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.

  14. Hamilton Rating Scale for Depression

    Time frame: At 3/6/12 months after onset

    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.

  15. Fatigue

    Time frame: At 12 months after onset

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaolin Chen, M.D.

CONTACT

[email protected]

13810624845

Sponsors and collaborators

Lead sponsor

Xiaolin Chen, MD

Other

Collaborators

  • Jiujiang No.1 People&amp;#39;s Hospital
  • Linyi People's Hospital
  • Peking University International Hospital
  • Qin Zhou NO.1 People&#39;s Hospital
  • Santai County People&amp;#39;s Hospital
  • Sichuan Academy of Medical Sciences
  • The First Affiliated Hospital of Shanxi Medical University
  • Zhangzhou Municipal Hospital of Fujian Province

Registry information

Official study title

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

Acronym: MCTAHS

Important dates

Study start
2020
Primary completion
2032
Study completion
2032
First posted
Sep 29, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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