【ChiCTR-OCH-13003951】實時三維超聲心動圖在缺血性功能性關閉不全的二尖瓣單張適應的前瞻性臨床研究

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基本信息

登记号

ChiCTR-OCH-13003951

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2013-12-02

临床申请受理号

靶点

适应症

Ischemic mitral regurgitation post first episode of myocardial infarction

试验通俗题目

實時三維超聲心動圖在缺血性功能性關閉不全的二尖瓣單張適應的前瞻性臨床研究

试验专业题目

實時三維超聲心動圖在缺血性功能性關閉不全的二尖瓣單張適應的前瞻性臨床研究

申办单位信息

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联系人邮编

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临床试验信息

试验目的

1. To confirm the clinical occurence of mitral leaflet adaptation in IMR by prospectively following up 2 MI cohorts, one with IMR, another without, using RT3DE to track changes in mitral leaflet, annular and left ventricular geometry from the acute to chronic phase of the disease; 2. To define the natural history of mitral leaflet adaptation with regard to its incidence, onset timing, durability, and extent by following up the study population for 1 year; 3. To test the hypothesis that inadequate leaflet adaptive enlargement to compensate for leaflet tethering contributes to the development of IMR by prospectively comparing IMR + and IMR- groups; 4. To explore the interactions between adaptive structural alteration taking placing in the mitral leaflets, annulus, and left ventricle, and their relationships with the development of IMR; 5. To identify potential factor(s) including clinical characteristics, echo cardiographic feathers, and therapeutic measures that may affect the occurrence and degree of mitral leaflet adaptation.

试验分类

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试验类型

队列研究

试验分期

其它

随机化

not applicable

盲法

试验项目经费来源

RGC-GRF

试验范围

目标入组人数

75;50

实际入组人数

第一例入组时间

2013-02-18

试验终止时间

2016-10-31

是否属于一致性

入选标准

Prospectively enrolled patients hospitalized for first episode of acute MI. 1. Diagnosis of MI is based on cardiac pain, newly developed Q waves, ST elevation/depression on ECG, and typical rise and fall of cardiac biomarkers (Troponin and/or CPK); 2. Patient will receive standard management for acute MI including medications and/or revascularization according to physician discretion; 3. All MI patients meeting the inclusion criteria will have serial transthoracic echocardiographic study including 2D/3D/TDI within 72 hours, in 7-14 days, and at 1 month post-MI. Patients will be separated into 2 groups based on presence or absence of IMR at 1 month, as defined by color flow imaging. The rationale of using 1 month for group separation is to avoid inclusion of transient MR due to acute ischemia, and is based on accepted definition of IMR in large epidemiological studies (2-4), as well as the time frame of ML adaptation in animal studies (13, 14, 17); 4. Healthy controls with normal history, physical examination and echocardiography matched for age, gender and body surface area will be enrolled from the community.；

排除标准

Prior MI or known left ventricular dysfunction, previous cardiac surgery, papillary muscle rupture, MR due to primary organic valve disease, associated aortic valve or congenital heart disease, poor image quality, and atrial fibrillation.；

研究者信息

研究负责人姓名

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试验机构

Research Grant Council

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