Acute Hemorrhagic StrokeMCTAHSNCT06061185
Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke
An observational study of Acute Hemorrhagic Stroke, run by Xiaolin Chen, MD at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Hemorrhagic Stroke
- What is being tested?
- Multimodal CT
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Apr 2032
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presented to the emergency department with hemorrhagic stroke.
Who may be able to join
- age ≥ 18, ≤ 85 years;
- presence with hemorrhagic stroke
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Xiaolin Chen, M.D., 13810624845, chenxiaolin@bjtth.org
About this study
Official title: Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke (MCTAHS)
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.
Read the 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.
- Conditions
- Acute Hemorrhagic Stroke
- Being tested
- Multimodal CT
- Keywords
- Acute Hemorrhagic Stroke, Multimodal CT, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal CTDevice
Non-contrast computed tomography, computed tomography angiography and computed tomography perfusion
| Study group | Role | What they receive |
|---|---|---|
| Testing populations | All patients with the possibility of acute hemorrhagic stroke and suitable for multimodal CT examination Receives: Device: Multimodal CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 3/6/12 months after onset
Secondary outcomes (15)
Mortality rate
Mortality rate as measured by death of a participant (binary outcome (yes/no)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After onset (max 30 days)
Hematoma expansion in intracerebral hemorrhage
non-contrast CT scan: the enlargement of hematoma ≥ 6ml
Measured: 24-48 hours from symptom onset
Recurrence of intracerebral hemorrhage
non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary bleeding
Measured: 90 days from symptom onset
Rebleeding of subarachnoid hemorrhage
Rebleeding Hemorrhage in subarachnoid space proven on CT/MR scan
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jan 2020
- Primary completion1 Mar 2032 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hemorrhagic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xiaolin Chen, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University International Hospital, Zhangzhou Municipal Hospital of Fujian Province, The First Affiliated Hospital of Shanxi Medical University, Santai County People&#39;s Hospital, Jiujiang No.1 People&#39;s Hospital, Qin Zhou NO.1 People's Hospital, Sichuan Academy of Medical Sciences, Linyi People's Hospital
- Responsible party
- Sponsor-investigator, Xiaolin Chen, MD, Beijing Tiantan Hospital
- Investigators
- Tu Li, M.D., Study chair, Beijing Tiantan HospitalZhenshan Song, M.D., Study chair, Beijing Tiantan HospitalRunting Li, M.D., Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061185
- Sponsor's protocol ID
- KY 2024-007-02
- Acronym
- MCTAHS
- Status last verified
- Apr 2025
- First submitted
- 10 Sep 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke (MCTAHS)
- ClinicalTrials.gov ID
- NCT06061185
- Acronym / sponsor ID
- MCTAHS / KY 2024-007-02
- Conditions
- Acute Hemorrhagic Stroke
- Keywords
- Acute Hemorrhagic Stroke, Multimodal CT, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Xiaolin Chen, MDUniversity, hospital or other
- Collaborators
- Peking University International Hospital, Zhangzhou Municipal Hospital of Fujian Province, The First Affiliated Hospital of Shanxi Medical University, Santai County People&#39;s Hospital, Jiujiang No.1 People&#39;s Hospital, Qin Zhou NO.1 People's Hospital, Sichuan Academy of Medical Sciences, Linyi People's Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2032 (estimated)
- Study completion
- 1 Apr 2032 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testing populations | – | Device: Multimodal CTAll patients with the possibility of acute hemorrhagic stroke and suitable for multimodal CT examination |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented to the emergency department with hemorrhagic stroke.
Key inclusion criteria (2 listed)
- age ≥ 18, ≤ 85 years;
- presence with hemorrhagic stroke
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal CTNon-contrast computed tomography, computed tomography angiography and computed tomography perfusion | Device | Testing populations |
Primary outcome
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
15 secondary outcomes
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
Hamilton Rating Scale for Anxiety
Time frame: At 3/6/12 months after onset
Hamilton Rating Scale for Depression
Time frame: At 3/6/12 months after onset
Fatigue
Time frame: At 12 months after onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tu Li, M.D. study chair
Beijing Tiantan Hospital
Zhenshan Song, M.D. study chair
Beijing Tiantan Hospital
Runting Li, M.D. study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hemorrhagic Stroke, run by Xiaolin Chen, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaolin Chen, M.D. (13810624845, chenxiaolin@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) (time frame: At 3/6/12 months after onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.