Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study Title: A real-world registry of multidisciplinary collaborative diagnosis and treatment models for cardioembolic stroke
Research Objectives:
â‘ 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.
â‘¡ 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:
â‘ 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.
â‘¡ 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
|
| |
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary joint diagnosis and treatment mode | Other | Multidisciplinary joint diagnosis and treatment mode,break down barriers and treat the heart and brain together |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular and cerebrovascular death, All-cause death, Cardiac insufficiency, Cognitive dysfunction | Cardiovascular and cerebrovascular death, All-cause death, Cardiac insufficiency, Cognitive dysfunction | 1.5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xingen Zhu, President | Second Affiliated Hospital of Nanchang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27211997 | Result | Lin SP, Long Y, Chen XH, Lin PY, Jiang HL. STAF score is a new simple approach for diagnosing cardioembolic stroke. Int J Neurosci. 2017 Mar;127(3):261-266. doi: 10.1080/00207454.2016.1185715. Epub 2016 May 25. | |
| 20595675 | Result | Marnane M, Duggan CA, Sheehan OC, Merwick A, Hannon N, Curtin D, Harris D, Williams EB, Horgan G, Kyne L, McCormack PM, Duggan J, Moore A, Crispino-O'Connell G, Kelly PJ. Stroke subtype classification to mechanism-specific and undetermined categories by TOAST, A-S-C-O, and causative classification system: direct comparison in the North Dublin population stroke study. Stroke. 2010 Aug;41(8):1579-86. doi: 10.1161/STROKEAHA.109.575373. Epub 2010 Jul 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2022 | Aug 10, 2022 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000083262 | Embolic Stroke |
| D001281 | Atrial Fibrillation |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Collect blood samples, tissues and body fluids according to the requirements of the sample bank
| 22922698 | Result | Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available. |
| 29362794 | Result | Friedman DJ, Piccini JP, Wang T, Zheng J, Malaisrie SC, Holmes DR, Suri RM, Mack MJ, Badhwar V, Jacobs JP, Gaca JG, Chow SC, Peterson ED, Brennan JM. Association Between Left Atrial Appendage Occlusion and Readmission for Thromboembolism Among Patients With Atrial Fibrillation Undergoing Concomitant Cardiac Surgery. JAMA. 2018 Jan 23;319(4):365-374. doi: 10.1001/jama.2017.20125. |
| 29544871 | Result | Lee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, Song JM, Kang DH, Kwon SU, Kang DW, Lee D, Kwon HS, Yun SC, Sun BJ, Park JH, Lee JH, Jeong HS, Song HJ, Kim J, Park SJ. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12. |
| 19764863 | Result | MacDougall NJ, Amarasinghe S, Muir KW. Secondary prevention of stroke. Expert Rev Cardiovasc Ther. 2009 Sep;7(9):1103-15. doi: 10.1586/erc.09.77. |
| 19379061 | Result | Khoo CW, Lip GY. Clinical outcomes of acute stroke patients with atrial fibrillation. Expert Rev Cardiovasc Ther. 2009 Apr;7(4):371-4. doi: 10.1586/erc.09.11. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |