Clinical trial NCT06465277: CMR Right Ventricular Contractile Reserve Following Lung Resection
Official title: Assessment of Right Ventricular Contractile Reserve Following Lung Resection by Dobutamine Stress Cardiac Magnetic Resonance: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Surgery
Anesthesia
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting for surgical resection of lung, oesophagus or stomach.

Brief summary: Feasibility study investigating CMR dobutamine stress testing before and after lung resection

Detailed description: We hypothesise that following lung resection,

1. 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),
2. 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.

Eligibility criteria: Inclusion Criteria:

* 1) Provision of informed consent 2) Age \>16 years 3) Planned elective

  1. lobectomy lung resection or
  2. oesophagectomy surgery with one lung ventilation or
  3. gastrectomy

Exclusion Criteria:

1. Pregnancy
2. On-going participation in any investigational research which could undermine the scientific basis of the study
3. Atrial fibrillation at baseline
4. 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
5. Lung resection specific

   1. Wedge, segmental or sub-lobar lung resection
   2. Pneumonectomy
   3. Isolated right middle lobectomy

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Primary outcomes:
measure: 1) Feasibility of dobutamine stress CMR to measure RVCreserve following lung resection.
timeFrame: Pre-operative and 2 months post-operative
Secondary outcomes:
measure: 1) Acceptability of the dobutamine stress CMR protocol to patients, by questionnaire
timeFrame: Pre-operative and 2 months post-operative
measure: 1) Acceptability of the dobutamine stress CMR protocol to patients, by completion
timeFrame: Pre-operative and 2 months post-operative
measure: 2) Incidence of complications related to dobutamine stress CMR
timeFrame: Pre-operative and 2 months post-operative
measure: 3) Change in RVCreserve change following lung resection
timeFrame: Pre-operative and 2 months post-operative
measure: 4) Change in PVreserve change following lung resection
timeFrame: Pre-operative and 2 months post-operative
measure: 5) Association between the changes in RVCreserve and markers of cardiac inflammation, BNP
timeFrame: Pre-operative and 2 months post-operative
measure: 5) Association between the changes in RVCreserve and markers of cardiac inflammation, hsTnT
timeFrame: Pre-operative and 2 months post-operative
measure: 1) Post-operative change in BNP
timeFrame: Peri-operative blood samples, pre-op, immediately post-op, post-op days 1 and 2, 4-8 weeks post-op
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
state: Northern Ireland
Study officials:
References: