Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke

NCT ID: NCT06061185

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2032-04-01

Brief Summary

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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

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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

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Acute Hemorrhagic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Testing populations

All patients with the possibility of acute hemorrhagic stroke and suitable for multimodal CT examination

Multimodal CT

Intervention Type DEVICE

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

Interventions

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Multimodal CT

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University International Hospital

OTHER

Sponsor Role collaborator

Zhangzhou Municipal Hospital of Fujian Province

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Santai County People's Hospital

UNKNOWN

Sponsor Role collaborator

Jiujiang No.1 People's Hospital

UNKNOWN

Sponsor Role collaborator

Qin Zhou NO.1 People's Hospital

UNKNOWN

Sponsor Role collaborator

Sichuan Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Linyi People's Hospital

OTHER

Sponsor Role collaborator

Xiaolin Chen, MD

OTHER

Sponsor Role lead

Responsible Party

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Xiaolin Chen, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tu Li, M.D.

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Zhenshan Song, M.D.

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Runting Li, M.D.

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaolin Chen, M.D.

Role: CONTACT

13810624845

Facility Contacts

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Xiaolin Chen, M.D.

Role: primary

13810624845

Other Identifiers

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KY 2024-007-02

Identifier Type: -

Identifier Source: org_study_id

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