CMR Right Ventricular Contractile Reserve Following Lung Resection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBelfast Health and Social Care Trust
About this trial
Feasibility study investigating CMR dobutamine stress testing before and after lung resection
Eligibility criteria
This trial accepts healthy volunteersQualifiers
1) Provision of informed consent 2) Age >16 years 3) Planned elective
lobectomy lung resection or
oesophagectomy surgery with one lung ventilation or
gastrectomy
Disqualifiers
Pregnancy
On-going participation in any investigational research which could undermine the scientific basis of the study
Atrial fibrillation at baseline
Any contraindication to
Trial population
Adult patients presenting for surgical resection of lung, oesophagus or stomach.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dobutamine stress CMR
Diagnostic testDobutamine 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.
Cardiac biomarker sample
Diagnostic testblood samples will be collected pre-operatively, in recovery, on post-operative days 1 and 2, and at 4-8 weeks post-operatively
Treatment groups
42 Participants
are divided into 3 treatment groupsGroup A: Lung resection2 interventions
Group B: Oesophagectomy1 intervention
Group C: Gastrectomy1 intervention
Trial outcomes
Primary outcomes
1
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-operativeSecondary outcomes
1
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-operative2
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-operative3
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-operative4
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-operativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov