An observational study in Lung Cancer, Surgery and Anesthesia, sponsored by Belfast Health and Social Care Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Belfast Health and Social Care Trust · Observational
Feasibility study investigating CMR dobutamine stress testing before and after lung resection
We hypothesise that following lung resection,
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.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 42 is below the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Belfast Health and Social Care Trust is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
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Adult patients presenting for surgical resection of lung, oesophagus or stomach.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1) Provision of informed consent 2) Age >16 years 3) Planned elective
Exclusion Criteria:
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
Isolated right middle lobectomy
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12 patients undergoing lobectomy. Pre and post-operative dobutamine stress CMR testing and cardiac biomarker testing.
Diagnostic Test: Dobutamine stress CMR · Diagnostic Test: Cardiac biomarker sample
15 patients Peri-operative cardiac biomarker testing.
Diagnostic Test: Cardiac biomarker sample
15 patients Peri-operative cardiac biomarker testing.
Diagnostic Test: Cardiac biomarker sample
Dobutamine stress testing will be undertaken in keeping with local departmental clinical guidelines with a graded increase in dobutamine infusion up to a maximum of 10microgram/kg/min. The patients' medications will be managed in keeping with the usual clinical practice and departmental guidelines. At rest and on each graded level of dobutamine infusion we will collect cine loops of the cardiac cycle including a short-axis stack of the ventricles, a four-chamber view and flow imaging perpendicular to the main, left and right pulmonary arteries. Post-processing will be dual reported by blinded observers using the Argus analysis software (Siemens) according to a standardised protocol. A safety report of each CMR scan will be generated by a consultant cardiologist, any abnormalities identified will be referred to the appropriate medical speciality and highlighted to the patient's clinical team.
blood samples will be collected pre-operatively, in recovery, on post-operative days 1 and 2, and at 4-8 weeks post-operatively
1) Feasibility of dobutamine stress CMR to measure RVCreserve following lung resection.
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.
Time frame: Pre-operative and 2 months post-operative
1) Acceptability of the dobutamine stress CMR protocol to patients, by questionnaire
Assessed by patient satisfaction questionnaires rate compared to our previous CMR studies that were performed without dobutamine stress testing.
Time frame: Pre-operative and 2 months post-operative
1) Acceptability of the dobutamine stress CMR protocol to patients, by completion
Assessed by patient recruitment/withdrawal rate compared to our previous CMR studies that were performed without dobutamine stress testing.
Time frame: Pre-operative and 2 months post-operative
2) Incidence of complications related to dobutamine stress CMR
We will assess for the onset of any of the following during the scan 1. New onset atrial fibrillation 2. Ventricular tachycardia 3. Angina, chest pain, shortness of breath and/or ischaemic ECG changes
Time frame: Pre-operative and 2 months post-operative
3) Change in RVCreserve change following lung resection
Comparison of the change in RVEF on stress pre- and post-operatively
Time frame: Pre-operative and 2 months post-operative
4) Change in PVreserve change following lung resection
Comparison of change in wave reflection on stress pre- and post-operatively
Time frame: Pre-operative and 2 months post-operative
5) Association between the changes in RVCreserve and markers of cardiac inflammation, BNP
Comparison of change in RVCreserve and the change in BNP
Time frame: Pre-operative and 2 months post-operative
5) Association between the changes in RVCreserve and markers of cardiac inflammation, hsTnT
Comparison of change in RVCreserve and the change in hsTnT.
Time frame: Pre-operative and 2 months post-operative
1) Post-operative change in BNP
Post-operative change in BNP in oesophagectomy compared to lung resection and gastrectomy.
Time frame: Peri-operative blood samples, pre-op, immediately post-op, post-op days 1 and 2, 4-8 weeks post-op
Plan to share: No
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Belfast Health and Social Care Trust