CMR Right Ventricular Contractile Reserve Following Lung Resection

Lung Cancer Clinical Trial

Official title:

Assessment of Right Ventricular Contractile Reserve Following Lung Resection by Dobutamine Stress Cardiac Magnetic Resonance: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06465277
• Other study ID #: awaited
• Status: Recruiting
• Start date: July 21, 2023
• Est. completion date: November 2024

Study information

• Verified date: June 2024
• Source: Belfast Health and Social Care Trust
• Contact: Adam Glass
• Phone: +442890976378
• Email: a.glass[@]qub.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: November 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Anesthesia
• Lung Cancer
• Surgery

Intervention

Diagnostic Test:
• Dobutamine stress CMR
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.
• Cardiac biomarker sample
blood samples will be collected pre-operatively, in recovery, on post-operative days 1 and 2, and at 4-8 weeks post-operatively

Locations

Country	Name	City	State
United Kingdom	Belfast Health and Social Care Trust	Belfast	Northern Ireland

Sponsors (1)

Lead Sponsor	Collaborator
Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-operative and 2 months post-operative
Secondary	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.	Pre-operative and 2 months post-operative
Secondary	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.	Pre-operative and 2 months post-operative
Secondary	2) Incidence of complications related to dobutamine stress CMR	We will assess for the onset of any of the following during the scan; New onset atrial fibrillation; Ventricular tachycardia; Angina, chest pain, shortness of breath and/or ischaemic ECG changes	Pre-operative and 2 months post-operative
Secondary	3) Change in RVCreserve change following lung resection	Comparison of the change in RVEF on stress pre- and post-operatively	Pre-operative and 2 months post-operative
Secondary	4) Change in PVreserve change following lung resection	Comparison of change in wave reflection on stress pre- and post-operatively	Pre-operative and 2 months post-operative
Secondary	5) Association between the changes in RVCreserve and markers of cardiac inflammation, BNP	Comparison of change in RVCreserve and the change in BNP	Pre-operative and 2 months post-operative
Secondary	5) Association between the changes in RVCreserve and markers of cardiac inflammation, hsTnT	Comparison of change in RVCreserve and the change in hsTnT.	Pre-operative and 2 months post-operative
Secondary	1) Post-operative change in BNP	Post-operative change in BNP in oesophagectomy compared to lung resection and gastrectomy.	Peri-operative blood samples, pre-op, immediately post-op, post-op days 1 and 2, 4-8 weeks post-op