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Study Title: A real-world study of valvular heart disease in Jiangxi Province
Research Objectives:
â‘ Main objectives: To examine the current incidence of valvular heart disease in Jiangxi Province, to establish a "Formal treatment model" for patients with valvular heart disease, and to manage the collection of diagnostic, therapeutic and prognostic data on patients.
â‘¡ Secondary objective: To investigate the composite of all-cause mortality, disabling stroke, permanent pacemaker implantation, and moderate or greater valve regurgitation in the "Formal treatment model" group and the "Conventional treatment model" group. The Conventional group was matched to patients who were not in the " Formal treatment model " during the same period.
Design type: a prospective, observational, real-world study (at least 1.5 years). No pre-established fixed treatment protocols, only a Formal treatment model,with all treatment choices made entirely by clinicians following relevant textbooks, expert consensus on clinical guidelines, and based on the patient's condition.
Subjects: All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023.
Summary of Research Protocol:
Study Title: A Real World Study of Valvular Heart Disease in Jiangxi Province
Research Objectives:
â‘ Main objectives: To examine the current incidence of valvular heart disease in Jiangxi Province, to establish a "Formal treatment model" for patients with valvular heart disease, and to manage the collection of diagnostic, therapeutic and prognostic data on patients.
â‘¡ Secondary objective: To investigate the composite of all-cause mortality, disabling stroke, permanent pacemaker implantation, and moderate or greater valve regurgitation in the "Formal treatment model" group and the "Conventional treatment model" group. The Conventional group was matched to patients who were not in the " Formal treatment model " during the same period.
Design type: a prospective, observational, real-world study (at least 1.5 years). No pre-established fixed treatment protocols, only a Formal treatment model,with all treatment choices made entirely by clinicians following relevant textbooks, expert consensus on clinical guidelines, and based on the patient's condition.
Subjects: All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023.
Formal treatment model group: Patients who agree and accept the surgical treatment recommendation (including medical and surgical treatment) enter the formal treatment model group.
Those who have received any of the following treatments (including but not limited to) as recommended by the standardized treatment process are considered to have received the standardized treatment, otherwise, they have not.
Conventional treatment model group: Patients who do not agree to enter the Formal treatment model group will automatically enter the Conventional treatment model group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Treatment group (Formal treatment model group): Patients who agree and accept the surgical treatment recommendation (including medical and surgical treatment) enter the formal treatment model group. Those who have received any of the following treatments (including but not limited to) as recommended by the standardized treatment process are considered to have received the standardized treatment, otherwise, they have not.
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| Control group | Control group(Conventional treatment model group):Patients who do not agree to enter the Formal treatment model group will automatically enter the Conventional treatment model group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formal treatment model | Other | Formal treatment model , no further surgery or minimally invasive treatment was performed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoints | all-cause mortality, disabling stroke, and incidence of cardiogenic stroke, permanent pacemaker implantation rate, and moderate or greater valve regurgitation at 1 year after surgery or discharge from treatment | 1 year after surgery or treatment |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Including cardiac death and non-cardiac death | surgery or 30 days after treatment |
| incidence of stroke | The incidence of stroke 30 days after discharge from hospital after surgery or treatment |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023.
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| Name | Affiliation | Role |
|---|---|---|
| Yanqing Wu, 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 |
|---|---|---|---|
| 23547127 | Result | Cary T, Pearce J. Aortic stenosis: pathophysiology, diagnosis, and medical management of nonsurgical patients. Crit Care Nurse. 2013 Apr;33(2):58-72. doi: 10.4037/ccn2013820. | |
| 27582763 | Result | Carita P, Coppola G, Novo G, Caccamo G, Guglielmo M, Balasus F, Novo S, Castrovinci S, Moscarelli M, Fattouch K, Corrado E. Aortic stenosis: insights on pathogenesis and clinical implications. J Geriatr Cardiol. 2016 Sep;13(6):489-98. doi: 10.11909/j.issn.1671-5411.2016.06.001. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2021 | Aug 23, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Collect blood samples, tissues and body fluids according to the requirements of the sample bank
| 30 days after discharge from hospital after surgery or treatment |
| rate of permanent pacemaker implantation | The rate of permanent pacemaker implantation after surgery or 30 days after treatment | surgery or 30 days after treatment |
| Moderate or higher valvular regurgitation | Moderate or higher valvular regurgitation after surgery or 30 days after discharge | immediately after the surgery or 30 days after discharge |
| Readmission rates for aortic stenosis and/or valve implantation-related complications | Readmission rates for aortic stenosis and/or valve implantation-related complications at 30 days and 1 year after surgery or treatment | 30 days and 1 year after surgery or treatment |
| The incidence of intraoperative temporary valve size replacement | including increasing or decreasing valve size | intraoperative |
| The incidence of abnormal valve position | including valve displacement, valve embolism, and valve ectopic release | during operation |
| The incidence of implantation of two or more valves | The incidence of implantation of two or more valves during aortic valve replacement | during aortic valve replacement |
| The Barthel index | The Barthel index was used to evaluate the health status of the subjects | 30 days and 1 year after surgery or treatment |
| NYHA classification | NYHA classification at 30 days and 1 year after discharge after surgery or treatment | 30 days and 1 year after discharge after surgery or treatment |
| 23062541 | Result | Dweck MR, Boon NA, Newby DE. Calcific aortic stenosis: a disease of the valve and the myocardium. J Am Coll Cardiol. 2012 Nov 6;60(19):1854-63. doi: 10.1016/j.jacc.2012.02.093. Epub 2012 Oct 10. |
| 26432749 | Result | Sathyamurthy I, Alex S. Calcific aortic valve disease: is it another face of atherosclerosis? Indian Heart J. 2015 Sep-Oct;67(5):503-6. doi: 10.1016/j.ihj.2015.07.033. Epub 2015 Aug 21. |
| 10814642 | Result | Soler-Soler J, Galve E. Worldwide perspective of valve disease. Heart. 2000 Jun;83(6):721-5. doi: 10.1136/heart.83.6.721. No abstract available. |