A Single-Center, Open-Label Study to Assess the Severity of Mitral Regurgitation With Multimodality Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- mitral regurgitant volume (RVol)
研究概览
简要总结
To investigate to assess the severity of mitral regurgitation by multimodality imaging.
详细描述
In the single-center and open-label study, the researcher will compare the changes of ultrasonic cardiography (UCG) parameters when patients in fasting, anaesthesia and rehydration firstly. The aims are to clarify the effect of fasting and anaesthesia on the assessment of mitral regurgitation (MR) severity and the corrective effect of intravenous rehydration. The researcher then will investigate the correlation and consistency of multimodality imaging in assessing the severity of mitral regurgitation. The aim is to acquire more accurate, objective and reproducible parameters, to provide new solution for the precise assessment of MR severity and to guide the selection of clinical treatment and timing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years old
- •all-caused moderate or severe MR assessed by Trans-Thoracic Echocardiography (TTE) : 1) EROA ≥0.3cm^2; 2) RVol ≥45ml
- •The patient has signed an informed consent form.
排除标准
- •unstable angina, acute myocardial infarction and surgical history of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) within 3 months before recruit
- •acute heart failure or acute worsening of chronic heart failure requiring vasoactive drug therapy
- •severe infections, septicaemia
- •severe hepatic insufficiency ( Child-Pugh class C)
- •severe renal insufficiency ( chronic kidney disease (CKD) stage 5: estimated glomerular filtration rate (eGFR) <15ml/min or dialysis)
- •hypotensive state, shock ( systolic blood pressure <90mmHg or mean arterial pressure <70mmHg with tissue hypoperfusion and urine output <30ml/h)
- •uncontrolled diseases of the haematological system: acute gastrointestinal bleeding, intracranial haemorrhage or haemorrhage from other organs, acute pulmonary embolism or deep vein thrombosis, congenital or acquired haemorrhagic disease such as haemophilia, anaphylactic purpura and acute leukaemia, severe abnormalities in haematological parameters such as platelet count <20*10^9/l and international normalized ratio (INR) >3
- •contraindication for Trans-Esophageal Echocardiography (TEE) such as oesophageal constriction, oesophageal tumour, oesophageal fistula, oesophageal varices, cervical vertebral instability
- •contraindication for CMR such as metal foreign matter in the body, claustrophobia
- •contraindication for intravenous anaesthesia such as allergy to anaesthetics
- •pregnancy or breastfeeding
- •The patient does not sign an informed consent form.
- •Due to other reasons the patient is not suitable for enrollment assessed by the researcher.
研究组 & 干预措施
UCG in pre-anaesthetic group
The fasting patients receive UCG in pre-anaesthetic.
干预措施: UCG (Diagnostic Test)
UCG in pre-anaesthetic group
The fasting patients receive UCG in pre-anaesthetic.
干预措施: fasting (Other)
UCG in post-anaesthetic group
The fasting patients receive UCG in post-anaesthetic.
干预措施: UCG (Diagnostic Test)
UCG in post-anaesthetic group
The fasting patients receive UCG in post-anaesthetic.
干预措施: fasting (Other)
UCG in post-rehydration group
The fasting patients in anaesthetised receive UCG in post-rehydration.
干预措施: rehydration (Other)
UCG in post-rehydration group
The fasting patients in anaesthetised receive UCG in post-rehydration.
干预措施: UCG (Diagnostic Test)
UCG in post-rehydration group
The fasting patients in anaesthetised receive UCG in post-rehydration.
干预措施: fasting (Other)
cardiac magnetic resonance （CMR） group
The non-fasting patients receive CMR in another time.
干预措施: CMR (Diagnostic Test)
结局指标
主要结局
mitral regurgitant volume (RVol)
时间窗: 1 day during an examination
RVol measured by multiple imaging methods when patient is in the different
effective regurgitant orifice area (EROA)
时间窗: 1 day during an examination
EROA measured by multiple imaging methods when patient is in the different situation.
mitral regurgitant fraction (RF)
时间窗: 1 day during an examination
RF measured by multiple imaging methods when patient is in the different
次要结局
未报告次要终点
研究者
Maohuan Lin
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University