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

August 10, 2022 updated by: Xiao Huang

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • The Second Affiliated Hospital of Nanchang University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at high risk of cardiogenic stroke in the Second Affiliated Hospital of Nanchang University and sub-centers of hospitals at all levels in Jiangxi Province from September 2022 to September 2023 were collected.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment group

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.
Other: Multidisciplinary joint diagnosis and treatment mode
Multidisciplinary joint diagnosis and treatment mode,break down barriers and treat the heart and brain together
Control group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite end point of cardiovascular and cerebrovascular events
Time Frame: 1.5 years
Non-fatal ischemic stroke, non-fatal hemorrhagic stroke, non-fatal myocardial infarction, non-fatal heart failure, cardiovascular and cerebrovascular death
1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular and cerebrovascular death, All-cause death, Cardiac insufficiency, Cognitive dysfunction
Time Frame: 1.5 years
Cardiovascular and cerebrovascular death, All-cause death, Cardiac insufficiency, Cognitive dysfunction
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiao Huang

Investigators

  • Principal Investigator: Xingen Zhu, President, Second Affiliated Hospital of Nanchang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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