Assessment of Right Ventricular Contractile Reserve Following Lung Resection by Dobutamine Stress Cardiac Magnetic Resonance: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- 1) Feasibility of dobutamine stress CMR to measure RVCreserve following lung resection.
研究概览
简要总结
Feasibility study investigating CMR dobutamine stress testing before and after lung resection
详细描述
We hypothesise that following lung resection,
- the subtle decrease in RV function and increase in afterload we have demonstrated at rest is associated with a marked impairment of RV function on exercise, termed impaired RV contractile reserve (RVCreserve),
- impaired RVCreserve is associated with impaired functional capacity .
In this study we aim to assess the feasibility of dobutamine stress cardiovascular magnetic resonance (CMR) scanning to assess RVCreserve pre- and post-operatively in patients undergoing lung resection.
Additionally, we hypothesise that one lung ventilation (with and without lung resection) is associated with biomarker evidence of RV injury.We will perform peri-operative cardiac biomarkers to differentiate between the contribution of major surgery (gastrectomy, lung resection and oesophagectomy), one lung ventilation (lung resection and oesophagectomy) and lung resection on RV injury.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent 2) Age >16 years 3) Planned elective
- •lobectomy lung resection or
- •oesophagectomy surgery with one lung ventilation or
- •gastrectomy
排除标准
- •On-going participation in any investigational research which could undermine the scientific basis of the study
- •Atrial fibrillation at baseline
- •Any contraindication to
- •a. CMR, i. Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant ii. Aneurysm clips iii. Metal injuries to the eye iv. Loose metal in a part of the body b. Dobutamine stress testing as per the Society for Cardiovascular Magnetic Resonance64 i. Severe systemic arterial hypertension (≥220/120 mmHg) ii. Unstable angina pectoris iii. Severe aortic valve stenosis (peak aortic valve gradient >60mmHg or aortic valve area < 1cm2) iv. Complex cardiac arrhythmias including uncontrolled atrial fibrillation v. Hypertrophic obstructive cardiomyopathy vi. Myocarditis, endocarditis, or pericarditis vii. Uncontrolled heart failure
- •Lung resection specific
- •Wedge, segmental or sub-lobar lung resection
- •Pneumonectomy
- •Isolated right middle lobectomy
结局指标
主要结局
1) Feasibility of dobutamine stress CMR to measure RVCreserve following lung resection.
时间窗: Pre-operative and 2 months post-operative
Reliability and variability will be assessed through dual reporting of the CMR images, testing intra-/inter-observer intraclass correlation coefficient (ICC) and coefficient of variation (CV). Study design will allow comparison to our previous resting studies published exercise literature and between pre- and post-operative imaging.
次要结局
- 1) Acceptability of the dobutamine stress CMR protocol to patients, by completion(Pre-operative and 2 months post-operative)
- 2) Incidence of complications related to dobutamine stress CMR(Pre-operative and 2 months post-operative)
- 1) Acceptability of the dobutamine stress CMR protocol to patients, by questionnaire(Pre-operative and 2 months post-operative)
- 3) Change in RVCreserve change following lung resection(Pre-operative and 2 months post-operative)
- 5) Association between the changes in RVCreserve and markers of cardiac inflammation, BNP(Pre-operative and 2 months post-operative)
- 4) Change in PVreserve change following lung resection(Pre-operative and 2 months post-operative)
- 5) Association between the changes in RVCreserve and markers of cardiac inflammation, hsTnT(Pre-operative and 2 months post-operative)
- 1) Post-operative change in BNP(Peri-operative blood samples, pre-op, immediately post-op, post-op days 1 and 2, 4-8 weeks post-op)