- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06051552
Prognostic Prediction Model in Patients With Moyamoya Disease Undergoing Revascularization Surgery
September 18, 2023 updated by: Ruquan Han, Beijing Tiantan Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ruquan Han, MD,PhD
- Phone Number: 861059976660
- Email: ruquan.han@gmail.com
Study Contact Backup
- Name: Xinyan Wang
- Email: alice1428656335@126.com
Study Locations
-
-
-
Beijing, China
- Capital Medical University, Beijing Tiantan Hospital
-
Contact:
- Ruquan Han
- Phone Number: 13701285393
- Email: ruquan.han@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Adult patients with moyamoya disease undergoing revascularization surgery
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 consecutive days after surgery
|
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)
|
2 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
September 18, 2023
First Submitted That Met QC Criteria
September 18, 2023
First Posted (Actual)
September 25, 2023
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 18, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WXY20230918
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Moyamoya Disease
-
Huashan HospitalActive, not recruiting
-
University Hospital TuebingenUniversity Hospital FreiburgNot yet recruiting
-
Great Ormond Street Hospital for Children NHS Foundation...Completed
-
Great Ormond Street Hospital for Children NHS Foundation...SuspendedMoyamoyaUnited Kingdom
-
Washington University School of MedicineNational Institute of Neurological Disorders and Stroke (NINDS)Completed
-
Seoul National University HospitalCompletedCarotid Artery, InternalKorea, Republic of
-
Ajou University School of MedicineCompletedIschemic Stroke | Moyamoya Disease | Angiogenesis | Ischemic Attack | Burr HoleKorea, Republic of
-
Seoul National University HospitalUnknownBrain Neoplasm | Intracranial Aneurysm | Cerebrovascular Moyamoya DiseaseKorea, Republic of
-
Stanford UniversityCompletedMoyamoya Disease | Cerebrovascular AccidentUnited States
-
Beijing Tiantan HospitalRecruiting