Lung CancerNCT06465277
CMR Right Ventricular Contractile Reserve Following Lung Resection
An observational study of Lung Cancer and Surgery, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
Feasibility study investigating CMR dobutamine stress testing before and after lung resection Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Surgery, Anesthesia
- What is being tested?
- Dobutamine stress CMR and Cardiac biomarker sample
- Type of treatment
- Injection or infusion
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jul 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients presenting for surgical resection of lung, oesophagus or stomach.
Who may be able to join
- 1) Provision of informed consent 2) Age >16 years 3) Planned elective
- lobectomy lung resection or
- oesophagectomy surgery with one lung ventilation or
- gastrectomy
Who cannot join
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
- Atrial fibrillation at baseline
- Any contraindication to
- 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
Show all 10Show fewer
- Wedge, segmental or sub-lobar lung resection
- Pneumonectomy
- Isolated right middle lobectomy
- -
Trial locations and contacts
1 site in 1 country.
Jon Silversides contact
United Kingdom1 site, 1 recruiting
- Recruiting
Belfast Health and Social Care Trust
Belfast, Northern Ireland, BT12 6BA
Jon Silversides, 02895041096, jon.silversides@belfasttrust.hscni.net
Adam Glass
About this study
Official title: Assessment of Right Ventricular Contractile Reserve Following Lung Resection by Dobutamine Stress Cardiac Magnetic Resonance: a Feasibility Study
Feasibility study investigating CMR dobutamine stress testing before and after lung resection
Read the detailed description
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.
- Conditions
- Lung Cancer, Surgery, Anesthesia
- Being tested
- Dobutamine stress CMR, Cardiac biomarker sample
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dobutamine stress CMRDiagnostic test
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 sampleDiagnostic test
blood samples will be collected pre-operatively, in recovery, on post-operative days 1 and 2, and at 4-8 weeks post-operatively
| Study group | Role | What they receive |
|---|---|---|
| Lung resection | 12 patients undergoing lobectomy. Pre and post-operative dobutamine stress CMR testing and cardiac biomarker testing. Receives: Diagnostic Test: Dobutamine stress CMR; Diagnostic Test: Cardiac biomarker sample | |
| Oesophagectomy | 15 patients Peri-operative cardiac biomarker testing. Receives: Diagnostic Test: Cardiac biomarker sample | |
| Gastrectomy | 15 patients Peri-operative cardiac biomarker testing. Receives: Diagnostic Test: Cardiac biomarker sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative and 2 months post-operative
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
- New onset atrial fibrillation
- Ventricular tachycardia
- Angina, chest pain, shortness of breath and/or ischaemic ECG changes
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Peri-operative blood samples, pre-op, immediately post-op, post-op days 1 and 2, 4-8 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start21 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465277
- Sponsor's protocol ID
- 22066JS-AS
- Status last verified
- Jun 2024
- First submitted
- 6 Sep 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Right Ventricular Contractile Reserve Following Lung Resection by Dobutamine Stress Cardiac Magnetic Resonance: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06465277
- Acronym / sponsor ID
- 22066JS-AS
- Conditions
- Lung Cancer, Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility study investigating CMR dobutamine stress testing before and after lung resection
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lung resection | – | Diagnostic Test: Dobutamine stress CMR, Diagnostic Test: Cardiac biomarker sample12 patients undergoing lobectomy. Pre and post-operative dobutamine stress CMR testing and cardiac biomarker testing. |
| Oesophagectomy | – | Diagnostic Test: Cardiac biomarker sample15 patients Peri-operative cardiac biomarker testing. |
| Gastrectomy | – | Diagnostic Test: Cardiac biomarker sample15 patients Peri-operative cardiac biomarker testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting for surgical resection of lung, oesophagus or stomach.
Key inclusion criteria (4 listed)
- 1) Provision of informed consent 2) Age >16 years 3) Planned elective
Key exclusion criteria (10 listed)
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
- Atrial fibrillation at baseline
- Any contraindication to
- Lung resection specific
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dobutamine stress CMRDobutamine 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. | Diagnostic test | Lung resection |
| Cardiac biomarker sampleblood samples will be collected pre-operatively, in recovery, on post-operative days 1 and 2, and at 4-8 weeks post-operatively | Diagnostic test | Gastrectomy, Lung resection, Oesophagectomy |
Primary outcome
1) Feasibility of dobutamine stress CMR to measure RVCreserve following lung resection.
Time frame: 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.
8 secondary outcomes
1) Acceptability of the dobutamine stress CMR protocol to patients, by questionnaire
Time frame: Pre-operative and 2 months post-operative
1) Acceptability of the dobutamine stress CMR protocol to patients, by completion
Time frame: Pre-operative and 2 months post-operative
2) Incidence of complications related to dobutamine stress CMR
Time frame: Pre-operative and 2 months post-operative
3) Change in RVCreserve change following lung resection
Time frame: Pre-operative and 2 months post-operative
4) Change in PVreserve change following lung resection
Time frame: Pre-operative and 2 months post-operative
5) Association between the changes in RVCreserve and markers of cardiac inflammation, BNP
Time frame: Pre-operative and 2 months post-operative
5) Association between the changes in RVCreserve and markers of cardiac inflammation, hsTnT
Time frame: Pre-operative and 2 months post-operative
1) Post-operative change in BNP
Time frame: Peri-operative blood samples, pre-op, immediately post-op, post-op days 1 and 2, 4-8 weeks post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Silversides contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Surgery, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Glass (+442890976378, a.glass@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) Feasibility of dobutamine stress CMR to measure RVCreserve following lung resection. (time frame: Pre-operative and 2 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.