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临床试验/NCT03523611
NCT03523611Unknown不适用

Cardiac Magnetic Resonance Assessment of Right Ventricular Inflammation After Lung Resection - a Feasibility Study

University of Glasgow1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年4月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
1
主要终点
Can RV inflammation be assessed by T1 mapping CMR following lung resection by assessing the number of CMR studies which have an IQS>1?

研究概览

简要总结

The purpose of this study is explore the impact of lung cancer surgery on inflammation and function of the right side of the heart.

详细描述

Lung cancer is the second most common cancer in the UK and is the leading cause of cancer related death. Where appropriate, surgery to remove the tumour and the surrounding lung (lung resection) provides the best chance of cure. Frequently patients are either current or ex-smokers with related lung or heart problems which increase the risks associated with surgery. Following surgery patients may suffer long term shortness of breath, greatly limiting their day-to-day function and lowering quality of life. The investigators believe this shortness of breath is not solely caused by the removal of part of the lung but also from a decrease in the performance of the heart. Although the surgery does not directly involve the heart it is thought that the damage is caused indirectly by the surgery and by the removal of part of the lung.

In a previous study, the investigators showed that the function of the right side of the heart (the right heart) is decreased following lung resection. The decrease in right heart (the part that supplies blood to the lungs) function was associated with a prolonged stay in the high dependency unit and blood markers indicating damage to the heart. The process by which the damage occurs is poorly understood, but it is thought that an increase in the forces preventing the right heart pumping blood (resistance) is to blame. The decrease in function in the right heart may be triggered during surgery by the diminished blood supply to the cancerous lung and, and maintained post operatively, as lung resection can cause a long-term increase in resistance.

Diseases that cause an increase in resistance to the right heart have been shown to cause damage to different parts of the right heart. An acute sudden increase in resistance can cause inflammation, thinning and scarring whilst a long-term increase in resistance causes the right heart to thicken. The investigators believe that the potential damage during the operation could cause permanent damage to the right heart and contribute to shortness of breath and functional limitation.

To investigate the potential inflammation/scarring and the function of the heart the investigators will image the heart with specialised Magnetic Resonance Imaging (MRI) scans.

The aim of the research is to determine whether inflammation occurs in the right heart during and following lung resection and, if so, does it result in scarring?. The investigators will compare the function of the right heart before, during and after surgery to determine if inflammation contributes to the decrease in right heart function following lung resection seen in our previous study. The investigators anticipate that the study will increase understanding of how the right heart may be damaged by lung resection. The investigators believe this will guide further studies aiming to prevent such damage, ultimately limiting the disabling breathlessness and decrease in heart function that so greatly affects patients' lives.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of informed consent
  • Age >16 years
  • Planned elective lung resection by VATS or open lobectomy

排除标准

  • On-going participation in any investigational research which could undermine the scientific basis of the study
  • Wedge, segmental or sub-lobar lung resection
  • Pneumonectomy
  • Isolated right middle lobectomy
  • Atrial fibrillation at baseline
  • Contraindication to cardiac magnetic resonance imaging
  • Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant
  • Aneurysm clips
  • Metal injuries to the eye
  • Loose metal in a part of the body
  • Contraindication to IV Gadolinium (contrast) administration:
  • Acute or chronic renal failure
  • Allergy to contrast

结局指标

主要结局

Can RV inflammation be assessed by T1 mapping CMR following lung resection by assessing the number of CMR studies which have an IQS>1?

时间窗: 2 months

The investigators will test and report inter- and intra-observer reproducibility of Region of Interest (ROI) definition in all datasets where Image Quality Score (IQS)\>1. The primary endpoint will be the number of MRI studies which have an IQS \>1.

次要结局

  • Are T1 values at the ventricular insertion points increased following lung resection?(2 months)
  • Association between RV inflammation and RV fibrosis following lung resection using measurement of extracellular volume?(2 months)
  • Is there any evidence of inflammation/fibrosis in the LV?(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Ben Shelley

Consultant Cardio-thoracic Anaesthesia and Critical Care

University of Glasgow

研究点 (1)

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