NCT05498909

A Real-world Registry Study of Multidisciplinary Collaborative Diagnosis and Treatment Model for Cardioembolic Stroke

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Xiao Huang · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Study Title: A real-world registry of multidisciplinary collaborative diagnosis and treatment models for cardioembolic stroke Research Objectives: ① Main objective: To establish a multidisciplinary assisted diagnosis and treatment model for patients at high risk of cardioembolic stroke, manage and collect the diagnosis, treatment and prognosis data of patients. ② Secondary objective: To investigate the improvement of cardioembolic stroke, cardiovascular complex events, recurrent stroke and all-cause mortality risk, quality of life, and cardiac function between the "multidisciplinary assisted treatment model" group and the "conventional treatment model group". The routine diagnosis and treatment mode can match the patients who did not adopt the "multidisciplinary assisted diagnosis and treatment mode" in the same period. Type of design: A prospective, observational, real-world study. No fixed diagnosis and treatment plan was established in advance, and only a multidisciplinary assisted diagnosis and treatment model was established. All treatment choices were made by clinicians according to the expert consensus of relevant textbooks and clinical guidelines, and according to the patient's condition. Subjects: From September 2022 to September 2023, high-risk patients with cardioembolic stroke were collected from the Second Affiliated Hospital of Nanchang University and sub-centers of hospitals at all levels in Jiangxi Province.

Detailed description

Summary of Research Protocol: Study Title: A real-world registry of multidisciplinary collaborative diagnosis and treatment models for cardioembolic stroke Research Objectives: ① Main objective: To establish a multidisciplinary assisted diagnosis and treatment model for patients at high risk of cardioembolic stroke, manage and collect the diagnosis, treatment and prognosis data of patients. ② Secondary objective: To investigate the improvement of cardioembolic stroke, cardiovascular complex events, recurrent stroke and all-cause mortality risk, quality of life, and cardiac function between the "multidisciplinary assisted treatment model" group and the "conventional treatment model group". The routine diagnosis and treatment mode can match the patients who did not adopt the "multidisciplinary assisted diagnosis and treatment mode" in the same period. Type of design: A prospective, observational, real-world study. No fixed diagnosis and treatment plan was established in advance, and only a multidisciplinary assisted diagnosis and treatment model was established. All treatment choices were made by clinicians according to the expert consensus of relevant textbooks and clinical guidelines, and according to the patient's condition. Subjects: From September 2022 to September 2023, high-risk patients with cardioembolic stroke were collected from the Second Affiliated Hospital of Nanchang University and sub-centers of hospitals at all levels in Jiangxi Province. Multidisciplinary assisted care mode group: Patients who agreed to and accepted the recommendation of multidisciplinary assisted care mode were enrolled in the multidisciplinary assisted care mode group. These patients would undergo further stroke (primary/secondary) prevention intervention. Those who received any of the following treatments, as recommended by the standard medical procedure, were considered to have received the standard medical treatment; otherwise, they were not. 1. Surgical procedures: left atrial appendage ligation, left atrial appendage clip, valve repair or replacement, etc. 2. Medical procedures: atrial fibrillation radiofrequency ablation, valvular closure, left atrial appendage closure, etc. 3. Anticoagulant drug therapy: standardized anticoagulant drug therapy. Routine treatment mode group: Patients who did not agree to enter the multidisciplinary treatment mode were automatically entered into the routine treatment mode group.

Conditions

• Cardioembolic Stroke
• Multidisciplinary Communication

Interventions

Type	Name	Description
OTHER	Multidisciplinary joint diagnosis and treatment mode	Multidisciplinary joint diagnosis and treatment mode,break down barriers and treat the heart and brain together

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-09-01
• Completion: 2024-06-30
• First posted: 2022-08-12
• Last updated: 2022-08-12

Locations

1 site across 1 country: China