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A Novel Automated & Comprehensive Approach for Ventricular Function Assessment in Heart Failure

2018年4月4日 更新者:National Heart Centre Singapore

Curvedness-based Imaging: A Novel Automated & Comprehensive Approach for Ventricular Function Assessment in Heart Failure

Heart failure is a major health care burden. It can occur with either normal or reduced LV ejection fraction, depending on different degrees of ventricular remodelling. The investigators recently published a new method, curvedness-based imaging. The investigators have also reported the diagnostic utility of curvedness-based imaging in various cardiac diseases. The investigators now propose to prospectively assess curvedness-based imaging for diagnosis of heart failure with normal ejection fraction and with reduced ejection fraction, and examine left ventricular systolic and diastolic function and predicts the prognosis in a cohort of HF patients.

研究概览

详细说明

Heart failure imposes major global health care burden on society and suffering for the individual.In the US, HF affects 5.7 million patients, and is the leading cause of hospitalization for people over 65 years, with 25% to 50% rate or hospital readmission within 6 months.In Singapore, between 1991 and 1998, it accounted for 4.5% of all hospital admissions and 2.5% of mortality in the geriatric age group.It confers an annual mortality of 10%.

The early diagnosis and identification of the underlying etiology of HF is of paramount importance; some causes require specific treatment and may be correctable. From updated American College of Cardiology/American Heart Association guidelines, some questions must be addressed for suspected HF patients: Is the left ventricular ejection fraction preserved or reduced? Is the structure of the LV normal or abnormal? Are there other structural abnormalities such as right ventricular (RV) abnormalities that could account for the clinical presentation? Is there LV global and regional dysfunction and to what extent? Is the etiology ischemic or non-ischemic?

Cardiac imaging is important both for HF diagnosis and monitoring of progress. Impaired pump function, expressed reduced left ventricular ejection fraction is often used as a marker of HF. About 50% of HF have preserved EF.In this situation, more intricate and comprehensive imaging involving measurement of multiple diastolic and systolic parameters, usually using echocardiography, may become necessary to address the questions mentioned above.

Our solution is expected to result in a significant cost saving for HF patients. HF diagnosis is still very challenging, consisting of assessment of medical and family histories, a physical exam and diagnostic imaging tests. The investigators compare the cost difference in traditional way against our proposed solution. The traditional diagnostic tests include chest x-ray, BNP blood test, echocardiography, nuclear heart scan and cardiac catheterization. In this project, the investigators estimate the cost of echocardiography, nuclear heart scan and cardiac catheterization for HF diagnosis. Based on clinical experience, among 1000 patients undergoing echocardiography, 50% will be referred to nuclear heart scan and 30% will be referred to invasive cardiac catheterization. The cost of the whole workup is estimated to be $1.95 million. If 1000 patients undergo our proposed CBI solution directly, the cost estimated at $1.4 million. The cost saving is estimated at S$400 per patient.

Hence, the investigators will be exploring the following for this study:

Primary aim: Assess LV systolic and diastolic function from curvedness-based imaging in 120 HF patients with reduced ejection fraction and normal ejection fraction.

Secondary aim: Evaluate the utility of curvedness-based imaging for the diagnosis of etiology of HF, against gold standard gadolinium enhanced CMR in subgroup of HF patients.

Exploratory aim: Evaluate the utility of curvedness-based imaging for the prediction of prognosis during 6 month follow up, where clinical outcome include death, CV death and HF re-admission.

研究类型

观察性的

注册 (实际的)

78

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Singapore、新加坡、169609
        • National Heart Centre Singapore

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic

描述

Inclusion Criteria:

  • Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic.
  • Written informed consent obtained

Exclusion Criteria:

  • Aged < 21 years
  • Contraindication to CMR examination.
  • Cardiac pacemaker
  • Brain aneurysm or clips
  • Electronic implants or prosthesis
  • Eye metal foreign body injury
  • Severe claustrophobia
  • Severe renal impairment, glomerular filtration rate < 30ml/min/1.73m2
  • Non-cardiac illness with life expectancy of less than 2 years
  • Previous heart, kidney, liver or lung transplantation.
  • HF primary due to severe valve disease
  • Other specific subgroups of HF: Including constrictive pericarditis, complex adult congenital heart disease, hypertrophic cardiomyopathy, eosinophilic myocarditis, cardiac amyloid and acute chemotherapy-induced cardiomyopathy.
  • Isolated right heart failure. Combined right and left heart failure will be included; Secondary to severe lung disease or pulmonary hypertension.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Heart Failure

Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic.

Cardiovascular Magnetic Resonance and Echocardiogram will be performed.

用于评估左心室容积、功能和质量。 这也是基于延迟增强成像技术评估心肌纤维化。
用于评估舒张和收缩功能以及瓣膜和心脏功能。 还将进行心室-动脉耦合。

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Allergic reaction due to MRI contrast
大体时间:Within first day of scan
Within first day of scan

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ru San Tan, MD、National Heart Centre Singapore

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年11月1日

初级完成 (实际的)

2017年8月1日

研究完成 (实际的)

2017年8月1日

研究注册日期

首次提交

2016年5月31日

首先提交符合 QC 标准的

2016年5月31日

首次发布 (估计)

2016年6月6日

研究记录更新

最后更新发布 (实际的)

2018年4月5日

上次提交的符合 QC 标准的更新

2018年4月4日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2013/934/C

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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