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

Xiao Huang

Status: Active, not recruiting

Conditions: Cardioembolic Stroke; Multidisciplinary Communication

Treatments: Other: Multidisciplinary joint diagnosis and treatment mode

Study type: Observational

Funder types: Other

Identifiers

NCT05498909

2022-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The risk of high embolism (including intracardiac thrombosis, intracardiac tumor, aortic atherosclerosis, atrial fibrillation and spontaneous ultrasound imaging) was in line with the risk stratification criteria of Chinese Expert Consensus on the Diagnosis of cardiogenic Stroke (2020);
• In accordance with the Chinese Expert Consensus on the Treatment of cardiogenic Stroke (2022), surgical indications for cardiac diseases (including left atrial appendage closure, left atrial appendage ligation, and radiofrequency ablation of atrial fibrillation are recommended for high-risk stroke patients with atrial fibrillation; For cryptogenic stroke patients with high-risk PFO, transcatheter PFO closure is recommended. Valve repair or replacement);
• Understand and voluntarily sign the informed consent.

Exclusion criteria

• Serious mental disorder, unable to express the will;
• In the judgment of the investigator, there are obvious other abnormal signs, laboratory tests and clinical diseases, which are not suitable for investigator participation;
• Researchers judged that long-term follow-up could not be completed

Trial design

1,200 participants in 2 patient groups

Treatment group

Description:

Treatment group（Multidisciplinary assisted treatment model group）： 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.

Treatment:

Other: Multidisciplinary joint diagnosis and treatment mode

Control group

Description:

Control group（Routine diagnosis and treatment model group）: Patients who did not agree to enter the multidisciplinary treatment mode were automatically admitted to the routine treatment mode group