The Pulmonary Vascular / Right Ventricular Response to Lung Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Right ventricular ejection fraction
研究概览
简要总结
The purpose of this study is explore the impact of lung cancer surgery on the function of the right side of the heart.
详细描述
Lung cancer is the second most common cancer in the UK. In suitable cases the best chance of cure is surgical resection. Studies suggest that lung resection is associated with right ventricular (RV) dysfunction, predisposing to complications and post-operative dyspnoea. Studies of RV function following lung resection have been hampered by the limitations of the techniques used. In addition the mechanism of RV dysfunction has remained elusive.
In this prospective observational study the RV response to lung resection will be characterised by sequential assessment of right ventricular ejection fraction (RVEF) measured using cardiovascular magnetic resonance (CMR). CMR is non-invasive, involves no ionising radiation and due to its high spatial resolution is the gold standard for assessing RV volumes. Comprehensive CMR and echocardiographic assessment of the pulmonary vascular - RV axis will allow us to interpret peri-operative changes in RVEF in the context of RV contractility and loading indices. In addition, contemporaneous blood samples will be taken for measurement of biomarkers of myocardial and endothelial dysfunction and systemic inflammation.
With increased understanding of the mechanisms involved, it may be possible to prevent RV dysfunction; reducing complication rates, hospital stay and costs and ameliorating long term dyspnoea.
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
- 否
入选标准
- •Provision of informed consent
- •Age >16 years
- •Planned elective lung resection by lobectomy
排除标准
- •On-going participation in any investigational research which could undermine the scientific basis of the study
- •Contraindications to magnetic resonance imaging:
- •i. Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant ii. Aneurysm clips iii. Metal injuries to the eye iv. Loose metal in an part of the body
- •Wedge / segmental / sub-lobar lung resection
- •Pneumonectomy
- •Isolated right middle lobectomy
结局指标
主要结局
Right ventricular ejection fraction
时间窗: 3 days
The primary objective of this study is determine whether RVEF falls post-operatively in patients undergoing lung resection. The primary outcome is RVEF at 3 days post-lung resection compared to pre-operative values determined by CMR.
次要结局
- Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF(3 days)
- RVEF vs LVEF(3 days)
- Association between RVEF and contractility / loading indices(3 days)
- Association between RVEF and functional status(3 months and 1 year)
研究者
Dr Ben Shelley
Clinical Research Fellow
University of Glasgow