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临床试验/NCT03046823
NCT03046823已完成不适用

Imaging-based Diagnosis of Diffuse Coronary Artery Disease and Quantification of Cardiac Remodeling in Obesity

National Heart Centre Singapore1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Diagnosis of diffuse coronary artery disease using imaging techniques and quantification of cardiac remodeling in obesity

研究概览

简要总结

The study aims to:

  1. Characterize coronary artery disease (CAD) using CT Angiography (CTA) and scaling power law in 100 patients with obesity
  2. Characterize cardiac remodeling using curvedness-based MRI in 100 patients with obesity
  3. Compare the differences of cardiac and vascular remodeling in patients with metabolic syndrome and those without

详细描述

Background and Objectives:

Obesity is a common [affecting about 33% in the general adult population in US] metabolic disorder and it is increasing in prevalence in Singapore (about 10% of general adult population). As obesity is associated with cardiovascular disease (i.e., diffused coronary artery disease, DCAD) and leads to heart remodeling and heart failure, timely and accurate diagnosis of diffused coronary artery disease and its related cardiac remodeling in obesity is clinically urgently needed and this study aims to:

  1. Characterize coronary artery disease (CAD) using CTA and scaling power law in 100 patients with obesity
  2. Characterize cardiac remodeling using curvedness-based MRI in 100 patients with obesity
  3. Compare the differences of cardiac and vascular remodeling in patients with metabolic syndrome and those without

Methodologies: 100 patients with obesity will be recruited for this study. All recruited patients will undergo fasting blood test for diagnosing metabolic syndrome. After that, they will undergo CTA and MRI within 1-2 weeks in-between. Patients' CTA images will be segmented and transformed to build 3D coronary artery models. The application of novel scaling power laws on these models will be used to diagnose diffuse CAD. Based on patients MRI images, the cardiac remodeling will be assessed with a novel curvedness-based imaging analysis method. The differences of cardiac and vascular remodeling in patients with metabolic syndrome and those without will be compared and analyzed.

In addition, subjects shall undergo ultrasound examination of the heart (echocardiogram), carotids and forearm arteries. Doppler and tissue-Doppler echocardiography constitutes the gold standard for cardiac diastolic function assessment. The findings shall be correlated with diastolic cine MRI findings. Carotid and forearm artery ultrasound allows investigation of vessel distensibility, carotid intimal thickness, pulse wave velocity, central arterial blood pressure estimation as well as endothelial function (via flow-mediated dilation). Perturbations of these parameters may be correlated with functional abnormalities on cardiac MRI and coronary disease on CT.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • with obesity BMI ≥27 .
  • Written informed consent obtained

排除标准

  • Individuals unable to provide informed consent.
  • Non-cardiac illness with life expectancy <2 years.
  • Pregnant state.
  • Allergy to iodinated contrast.
  • Significant arrhythmia; heart rate ≥ 100 beats/min; systolic blood pressure ≤90 mmHg.
  • Renal dysfunction (Glomerular filtration rate (GFR) <45 mL/min/1.73m2).
  • Contraindication to beta blockers or nitroglycerin.
  • Canadian Cardiovascular Society class IV angina.
  • with Cardiac pacemaker
  • with brain aneurysm or clips
  • with Electronic implants or prosthesis
  • with Eye metal foreign body injury
  • Severe claustrophobia
  • Thyroid dysfunction

结局指标

主要结局

Diagnosis of diffuse coronary artery disease using imaging techniques and quantification of cardiac remodeling in obesity

时间窗: 36 months

Imaging-based techniques used are MRI, CTA and Echocardiogram. Fasting blood tests will be carried out to determine metabolic syndrome. Cardiac and vascular remodeling in participants with metabolic syndrome and those without will be compared and analyzed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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