Prognostic Prediction Model in Patients With Moyamoya Disease Undergoing Revascularization Surgery

Moyamoya Disease Clinical Trial

Official title:

Development and Validation for Muti-stage Prognostic Prediction Model in Patients With Moyamoya Disease Undergoing Revascularization Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06051552
• Other study ID #: WXY20230918
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: September 2023
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, MD,PhD
• Phone: 861059976660
• Email: ruquan.han[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: September 30, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than or equal to 18 years.

2. Imaging-confirmed moyamoya disease (CTA, CT angiography; MRA, magnetic resonance angiography;DSA, digital subtraction angiography)for MMD patients.

3. Selective Revascularization Surgery (direct or indirect);

4. Signed informed consent by the patient or legal representative.

Exclusion Criteria:

1. patients with moyamoya syndrome due to an established secondary etiology.

2. with severe cardiopulmonary disease that, in the opinion of the investigator, makes them unsuitable for participation in this study.

3. patients with a life expectancy of less than 3 months or otherwise unable to complete this study.

4. contraindication to DSA examination, severe contrast allergy or absolute contraindication to iodine contrast;

5. women of childbearing age who have a negative pregnancy test but refuse to use effective contraception.

6. women during pregnancy or breastfeeding.

7. those who are unable to complete the study due to psychiatric disorders, cognitive or mood disorders.

8. other patients who, in the opinion of the investigator, are not suitable for enrollment in the study (indicate reason).

Related Conditions & MeSH terms

• Moyamoya Disease

Locations

Country	Name	City	State
China	Capital Medical University, Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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