RadiologyNCT06890468
Three-in-One Stop Computed Topography Angiography(CTA) and CT Perfusion(CTP) in Cerebrovascular Disease
An observational study of Radiology and Vascular Diseases, run by Xin Lou at 1 site in China.
Trial summary
This research takes patients with cerebrovascular diseases as the research subjects and employs the experimental design of a prospective cohort study, aiming to innovatively develop and validate a "one-stop" multimodal CT examination scheme. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radiology, Vascular Diseases
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2025to 30 Dec 2029
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cerebrovascular disease
Who may be able to join
- Age≥18 <100years
- Head and neck artery stenosis/occlusion, moyamoya disease, aneurysm, artery dissection, etc., may include patients with acute stroke, chronic cerebral ischemia, and asymptomatic patients. After clinical assessment, CT perfusion imaging is required
- The image quality meets the requirements of diagnosis and post-processing
- Patients who follow the scanning strategy to complete the examination
- The patient or his or her family agrees to provide clinical data and follow-up
- Patients or their families sign informed consent forms
Who cannot join
- < 18 years old
- People who are allergic to iodine contrast agents, or who cannot be tested temporarily due to taking metformin or aminoglycoside drugs
- Renal failure patient
- Severe cardiac insufficiency
- Severe liver damage
- Patients with an expected survival of less than 1 year
- Patients with cerebrovascular diseasePregnant woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Three-in-One Stop Computed Topography Angiography and CT Perfusion in Cerebrovascular Disease
This research takes patients with cerebrovascular diseases as the research subjects and employs the experimental design of a prospective cohort study, aiming to innovatively develop and validate a "one-stop" multimodal CT examination scheme. The 301-CTAP multimodal CT technique implies that three modalities are acquired through a single collection, including head and neck CTA (head and neck CTA), multiphase CTA imaging of the brain (multiphase CTA), and CT perfusion imaging of the brain (CT perfusion).
Read the detailed description
In the diagnosis of cerebrovascular diseases, CT examination, with its advantages of high resolution, non-invasiveness, and rapid imaging, has long become an indispensable diagnostic tool. Especially in the "Chinese Guidelines for the Standardized Application of Cerebrovascular Disease Imaging", the "one-stop" CT examination mode - including CT plain scan (NCCT), CT angiography (CTA), and CT perfusion imaging (CTP) - has been strongly recommended as the preferred imaging examination method for suspected acute large artery occlusion ischemic cerebrovascular diseases. However, traditional multimodal CT examinations require large amounts of contrast agents, multiple scans for blood flow and vascular imaging, multiple injections of contrast agents, high radiation doses, and low image signal-to-noise ratios. How to simultaneously evaluate cerebral blood flow perfusion and cerebral vessels through a single examination is a major clinical need that urgently needs to be addressed.
This study takes patients with cerebrovascular diseases as the research subjects and adopts a prospective cohort study design. The aim is to innovatively develop and verify a "one-stop" multimodal CT examination scheme. The 301-CTAP multimodal CT technology means that the three modalities are obtained through a single acquisition, including head and neck CTA (CTA), multiphase CTA (CTA) imaging of the brain, and CT perfusion imaging of the brain. The 301-CTAP multimodal CT technology can reduce the duration of CT examination for patients with cerebrovascular diseases without reducing the imaging content, and reduce the amount of contrast agents, X-ray radiation dose, and the incidence of contrast agent allergy and related adverse events. It provides innovative and important technical support for the diagnosis and assessment of acute stroke and other cerebrovascular emergencies; the acquisition of multiple key imaging indicators features enables individualized comprehensive imaging assessment, prediction of clinical functional prognosis and stroke recurrence risk for patients; the implementation of this project helps optimize the imaging examination path in the diagnosis and treatment of cerebrovascular diseases.
- Conditions
- Radiology, Vascular Diseases
- Keywords
- CTP, head and neck CTA
- Medical subject headings
- Vascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-in-One Stop Computed Topography Angiography and Perfusion（301-CTAP） in the diagnosis of cerebrovascular disease performance description
Three-in-One Stop computed topography angiography and computed topography perfusion in cerebrovascular disease performance, including lesions in the detection and imaging in the diagnosis of image quality, accuracy, sensitivity and specificity.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start16 Mar 2025 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiologyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xin Lou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890468
- Sponsor's protocol ID
- 301-CTAP
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-in-One Stop Computed Topography Angiography and CT Perfusion in Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT06890468
- Acronym / sponsor ID
- 301-CTAP
- Conditions
- Radiology, Vascular Diseases
- Keywords
- CTP, head and neck CTA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xin LouUniversity, hospital or other
- Study start
- 16 Mar 2025 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 24 Mar 2025 (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.
This research takes patients with cerebrovascular diseases as the research subjects and employs the experimental design of a prospective cohort study, aiming to innovatively develop and validate a "one-stop" multimodal CT examination scheme. The 301-CTAP multimodal CT technique implies that three modalities are acquired through a single collection, including head and neck CTA (head and neck CTA), multiphase CTA imaging of the brain (multiphase CTA), and CT perfusion imaging of the brain (CT perfusion).
Detailed description
In the diagnosis of cerebrovascular diseases, CT examination, with its advantages of high resolution, non-invasiveness, and rapid imaging, has long become an indispensable diagnostic tool. Especially in the "Chinese Guidelines for the Standardized Application of Cerebrovascular Disease Imaging", the "one-stop" CT examination mode - including CT plain scan (NCCT), CT angiography (CTA), and CT perfusion imaging (CTP) - has been strongly recommended as the preferred imaging examination method for suspected acute large artery occlusion ischemic cerebrovascular diseases. However, traditional multimodal CT examinations require large amounts of contrast agents, multiple scans for blood flow and vascular imaging, multiple injections of contrast agents, high radiation doses, and low image signal-to-noise ratios. How to simultaneously evaluate cerebral blood flow perfusion and cerebral vessels through a single examination is a major clinical need that urgently needs to be addressed.
This study takes patients with cerebrovascular diseases as the research subjects and adopts a prospective cohort study design. The aim is to innovatively develop and verify a "one-stop" multimodal CT examination scheme. The 301-CTAP multimodal CT technology means that the three modalities are obtained through a single acquisition, including head and neck CTA (CTA), multiphase CTA (CTA) imaging of the brain, and CT perfusion imaging of the brain. The 301-CTAP multimodal CT technology can reduce the duration of CT examination for patients with cerebrovascular diseases without reducing the imaging content, and reduce the amount of contrast agents, X-ray radiation dose, and the incidence of contrast agent allergy and related adverse events. It provides innovative and important technical support for the diagnosis and assessment of acute stroke and other cerebrovascular emergencies; the acquisition of multiple key imaging indicators features enables individualized comprehensive imaging assessment, prediction of clinical functional prognosis and stroke recurrence risk for patients; the implementation of this project helps optimize the imaging examination path in the diagnosis and treatment of cerebrovascular diseases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cerebrovascular disease
Key inclusion criteria (6 listed)
- Age≥18 <100years
- Head and neck artery stenosis/occlusion, moyamoya disease, aneurysm, artery dissection, etc., may include patients with acute stroke, chronic cerebral ischemia, and asymptomatic patients. After clinical assessment, CT perfusion imaging is required
- The image quality meets the requirements of diagnosis and post-processing
- Patients who follow the scanning strategy to complete the examination
- The patient or his or her family agrees to provide clinical data and follow-up
Key exclusion criteria (7 listed)
- < 18 years old
- People who are allergic to iodine contrast agents, or who cannot be tested temporarily due to taking metformin or aminoglycoside drugs
- Renal failure patient
- Severe cardiac insufficiency
- Severe liver damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Three-in-One Stop Computed Topography Angiography and Perfusion（301-CTAP） in the diagnosis of cerebrovascular disease performance description
Time frame: 2 years
Three-in-One Stop computed topography angiography and computed topography perfusion in cerebrovascular disease performance, including lesions in the detection and imaging in the diagnosis of image quality, accuracy, sensitivity and specificity.
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 24 Mar 2025.
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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.
Xin Lou study chair
Chinese PLA General 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 Radiology and Vascular Diseases, run by Xin Lou 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 6 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: opening soon, as of the sponsor's last update on 24 Mar 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 xiaoxuan Ma (+8613681126807, xiaoxuan5686@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-in-One Stop Computed Topography Angiography and Perfusion（301-CTAP） in the diagnosis of cerebrovascular disease performance description (time frame: 2 years). 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 24 Mar 2025.