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CMR Right Ventricular Contractile Reserve Following Lung Resection

Sponsor: Belfast Health and Social Care Trust

NCT ID: NCT06465277

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Dobutamine stress CMR (diagnostic test), Cardiac biomarker sample (diagnostic test)
How long the study runs
Study runs about 17 months (dates as stated)
About the drug or intervention
Dobutamine stress CMR — diagnostic 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. · Cardiac biomarker sample — diagnostic test: blood samples will be collected pre-operatively, in recovery, on post-operative days 1 and 2, and at 4-8 weeks post-operatively
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
42
Started
2023-07-21
Last checked
2024-06

Plain English Summary

What is this study?

  • • Testing a new treatment for lung cancer
  • • Clinical study - 42 participants
  • • Feasibility study investigating CMR dobutamine stress testing before and after lung resection

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with lung cancer

Where?

  • • Belfast - Belfast Health and Social Care Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

Lung CancerSurgeryAnesthesia

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓1\) Provision of agreement to take part 2) Age \>16 years 3) Planned elective
  • ✓lobectomy lung resection or
  • ✓oesophagectomy surgery with one lung ventilation or
  • ✓gastrectomy

Who cannot take part

  • ✗Pregnancy
  • ✗On-going participation in any investigational research which could undermine the scientific basis of the study
  • ✗Atrial fibrillation at baseline
  • ✗Any safety concern to
  • ✗Lung resection specific
See the full 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 \-

Where Is This Study? (1 UK site)

Belfast Health and Social Care Trust

Belfast BT12 6BA, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Adam Glass

Sponsor contact

CONTACT

+442890976378 a.glass@qub.ac.uk

Jon Silversides

Sponsor contact

CONTACT

j.silversides@qub.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-06