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

Multidisciplinary Communication Clinical Trial

— CSMDT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05498909
• Other study ID #: 2022-01
• Status: Active, not recruiting
• Start date: August 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2022
• Source: Second Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardioembolic Stroke
• Embolic Stroke
• Multidisciplinary Communication
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Xiao Huang

Country where clinical trial is conducted

China, 

References & Publications (7)

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 Wi — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. Review. — View Citation

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 T — View Citation

Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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