An observational study in Cardioembolic Stroke and Multidisciplinary Communication, sponsored by Xiao Huang. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2022-08-12.
Sponsored by Xiao Huang · Observational
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.
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.
Routine treatment mode group: Patients who did not agree to enter the multidisciplinary treatment mode were automatically entered into the routine treatment mode group.
40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 364 across 27 observational studies indexed under Embolic Stroke.
Browse Embolic Stroke studies →Xiao Huang is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Multidisciplinary joint diagnosis and treatment mode,break down barriers and treat the heart and brain together
Composite end point of cardiovascular and cerebrovascular events
Non-fatal ischemic stroke, non-fatal hemorrhagic stroke, non-fatal myocardial infarction, non-fatal heart failure, cardiovascular and cerebrovascular death
Time frame: 1.5 years
Cardiovascular and cerebrovascular death, All-cause death, Cardiac insufficiency, Cognitive dysfunction
Cardiovascular and cerebrovascular death, All-cause death, Cardiac insufficiency, Cognitive dysfunction
Time frame: 1.5 years
Plan to share: Undecided
Started Aug 2022 (actual). Primary completion is estimated for Sep 2023, 13 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Xiao Huang