Prognostic Prediction Model in Patients With Moyamoya Disease Undergoing Revascularization Surgery

NCT06051552 | Not Yet Recruiting DMC

• 1 other identifier: WXY20230918
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  2 weeks after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with moyamoya disease undergoing revascularization surgery

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Capital Medical University, Beijing Tiantan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ruquan Han, MD,PhD

CONTACT

861059976660; ruquan.han@gmail.com

Xinyan Wang

CONTACT

alice1428656335@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Director

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: October 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 25, 2023

Record last verified: 2023-09

Locations

CN (1)