Moyamoya DiseaseNCT06051552
Prognostic Prediction Model in Patients With Moyamoya Disease Undergoing Revascularization Surgery
An observational study of Moyamoya Disease, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Moyamoya Disease (MMD) is a rare chronic cerebrovascular disease characterized by progressive occlusion of the internal carotid artery or its major branches, with blood flow compensated by the formation of an abnormal vascular network (smoky). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moyamoya Disease
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with moyamoya disease undergoing revascularization surgery
Who may be able to join
- Age greater than or equal to 18 years.
- Imaging-confirmed moyamoya disease (CTA, CT angiography; MRA, magnetic resonance angiography；DSA, digital subtraction angiography）for MMD patients.
- Selective Revascularization Surgery (direct or indirect);
- Signed informed consent by the patient or legal representative.
Who cannot join
- patients with moyamoya syndrome due to an established secondary etiology.
- with severe cardiopulmonary disease that, in the opinion of the investigator, makes them unsuitable for participation in this study.
- patients with a life expectancy of less than 3 months or otherwise unable to complete this study.
- contraindication to DSA examination, severe contrast allergy or absolute contraindication to iodine contrast;
- women of childbearing age who have a negative pregnancy test but refuse to use effective contraception.
- women during pregnancy or breastfeeding.
- those who are unable to complete the study due to psychiatric disorders, cognitive or mood disorders.
- other patients who, in the opinion of the investigator, are not suitable for enrollment in the study (indicate reason).
Trial locations and contacts
1 site in 1 country.
Xinyan Wang contact
China1 site
Capital Medical University, Beijing Tiantan Hospital
Beijing
Ruquan Han, 13701285393, ruquan.han@gmail.com
About this study
Official title: Development and Validation for Muti-stage Prognostic Prediction Model in Patients With Moyamoya Disease Undergoing Revascularization Surgery
Moyamoya Disease (MMD) is a rare chronic cerebrovascular disease characterized by progressive occlusion of the internal carotid artery or its major branches, with blood flow compensated by the formation of an abnormal vascular network (smoky). According to the latest national epidemiological survey in 2022, the cumulative number of new cases in the population was 47,443 in two years, with the annual incidence rate increasing year by year. The first symptoms are mainly cerebral infarction, transient ischemic attack, intracranial hemorrhage, and epileptic seizure, and the onset of the disease is concentrated in the age group of 45-54 years old, which is one of the most important causes of new strokes in middle-aged and young people and imposes a heavy medical burden on the society and the family. As one of the major causes of new strokes in young and middle-aged people, it brings a heavy medical burden to society and families. Hemodialysis has been confirmed as a standard treatment for patients with smokers' disease in large sample studies to prevent bleeding and recurrence of hemorrhage; however, there is no better consensus on which anesthetic technique to use for hemodialysis in patients with MMD. Currently, the more perfect prediction model is the postoperative collateral compensation formation prediction model for direct and indirect hemodialysis, which has the advantage of making full use of the patients' preoperative baseline variables and imaging characteristics, but the relatively insufficient inclusion of the sample size and the lack of intraoperative (vital signs, respiratory parameters, local cerebral oxygenation, etc.) and postoperative (postoperative neurological injury markers, etc.) variables included in the model limits the clinical scenarios. The lack of intraoperative (vital signs, respiratory parameters, local cerebral oxygen saturation) and postoperative (postoperative neurologic injury markers) variables limits the clinical application scenarios and is unable to guide the clinical decision-making and prognosis in the important stages of the perioperative period. This study aims to establish a prospective cohort database for MMD hemodialysis that includes perioperative anesthesia management, intraoperative treatment data, and postoperative treatment variables; to integrate preoperative, intraoperative, postoperative, and near- and long-term prognostic data from multiple sources, and to construct a perioperative multi-stage, multi-dimensional prognostic prediction model.
- Conditions
- Moyamoya Disease
- Keywords
- Perioperative management, Moyamoya Disease, Predictive Model, Revascularization Surgery, Anesthesia
- Medical subject headings
- Moyamoya Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Postoperative assessment using 3D-CAM or CAM-ICU was performed at a fixed time slot each day for 3 consecutive days, and postoperative visits were performed at the patient's bedside from 10:00 am to 16:00 pm.
Measured: 3 consecutive days after surgery
Incidence of postoperative cerebral ischemic event
categorization of cerebral ischemic complications based on typical symptoms occurring within 2 weeks after surgery, and signs of new ischemia confirmed by postoperative radiology (e.g., computed tomography (CT), CT perfusion, or diffusion-weighted imaging)
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051552
- Sponsor's protocol ID
- WXY20230918
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation for Muti-stage Prognostic Prediction Model in Patients With Moyamoya Disease Undergoing Revascularization Surgery
- ClinicalTrials.gov ID
- NCT06051552
- Acronym / sponsor ID
- WXY20230918
- Conditions
- Moyamoya Disease
- Keywords
- Perioperative management, Moyamoya Disease, Predictive Model, Revascularization Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 25 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.
Moyamoya Disease (MMD) is a rare chronic cerebrovascular disease characterized by progressive occlusion of the internal carotid artery or its major branches, with blood flow compensated by the formation of an abnormal vascular network (smoky). According to the latest national epidemiological survey in 2022, the cumulative number of new cases in the population was 47,443 in two years, with the annual incidence rate increasing year by year. The first symptoms are mainly cerebral infarction, transient ischemic attack, intracranial hemorrhage, and epileptic seizure, and the onset of the disease is concentrated in the age group of 45-54 years old, which is one of the most important causes of new strokes in middle-aged and young people and imposes a heavy medical burden on the society and the family. As one of the major causes of new strokes in young and middle-aged people, it brings a heavy medical burden to society and families. Hemodialysis has been confirmed as a standard treatment for patients with smokers' disease in large sample studies to prevent bleeding and recurrence of hemorrhage; however, there is no better consensus on which anesthetic technique to use for hemodialysis in patients with MMD. Currently, the more perfect prediction model is the postoperative collateral compensation formation prediction model for direct and indirect hemodialysis, which has the advantage of making full use of the patients' preoperative baseline variables and imaging characteristics, but the relatively insufficient inclusion of the sample size and the lack of intraoperative (vital signs, respiratory parameters, local cerebral oxygenation, etc.) and postoperative (postoperative neurological injury markers, etc.) variables included in the model limits the clinical scenarios. The lack of intraoperative (vital signs, respiratory parameters, local cerebral oxygen saturation) and postoperative (postoperative neurologic injury markers) variables limits the clinical application scenarios and is unable to guide the clinical decision-making and prognosis in the important stages of the perioperative period. This study aims to establish a prospective cohort database for MMD hemodialysis that includes perioperative anesthesia management, intraoperative treatment data, and postoperative treatment variables; to integrate preoperative, intraoperative, postoperative, and near- and long-term prognostic data from multiple sources, and to construct a perioperative multi-stage, multi-dimensional prognostic prediction model.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with moyamoya disease undergoing revascularization surgery
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years.
- Imaging-confirmed moyamoya disease (CTA, CT angiography; MRA, magnetic resonance angiography；DSA, digital subtraction angiography）for MMD patients.
- Selective Revascularization Surgery (direct or indirect);
- Signed informed consent by the patient or legal representative.
Key exclusion criteria (8 listed)
- patients with moyamoya syndrome due to an established secondary etiology.
- with severe cardiopulmonary disease that, in the opinion of the investigator, makes them unsuitable for participation in this study.
- patients with a life expectancy of less than 3 months or otherwise unable to complete this study.
- contraindication to DSA examination, severe contrast allergy or absolute contraindication to iodine contrast;
- women of childbearing age who have a negative pregnancy test but refuse to use effective contraception.
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
Incidence of postoperative delirium
Time frame: 3 consecutive days after surgery
Postoperative assessment using 3D-CAM or CAM-ICU was performed at a fixed time slot each day for 3 consecutive days, and postoperative visits were performed at the patient's bedside from 10:00 am to 16:00 pm.
Incidence of postoperative cerebral ischemic event
Time frame: 2 weeks after surgery
categorization of cerebral ischemic complications based on typical symptoms occurring within 2 weeks after surgery, and signs of new ischemia confirmed by postoperative radiology (e.g., computed tomography (CT), CT perfusion, or diffusion-weighted imaging)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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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. This study is not recruiting at the moment.
Xinyan Wang contact
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 Moyamoya Disease, run by Beijing Tiantan Hospital 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, MD,PhD (861059976660, ruquan.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: 3 consecutive days after surgery). The study lists 2 primary outcomes in all. 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 25 Sep 2023.