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CMR Right Ventricular Contractile Reserve Following Lung Resection

B

Belfast Health and Social Care Trust

Status

Enrolling

Conditions

Surgery
Lung Cancer
Anesthesia

Treatments

Diagnostic Test: Dobutamine stress CMR
Diagnostic Test: Cardiac biomarker sample

Study type

Observational

Funder types

Other

Identifiers

NCT06465277
22066JS-AS

Details and patient eligibility

About

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

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

42 participants in 3 patient groups

Lung resection
Description:
12 patients undergoing lobectomy. Pre and post-operative dobutamine stress CMR testing and cardiac biomarker testing.
Treatment:
Diagnostic Test: Cardiac biomarker sample
Diagnostic Test: Dobutamine stress CMR
Oesophagectomy
Description:
15 patients Peri-operative cardiac biomarker testing.
Treatment:
Diagnostic Test: Cardiac biomarker sample
Gastrectomy
Description:
15 patients Peri-operative cardiac biomarker testing.
Treatment:
Diagnostic Test: Cardiac biomarker sample

Trial contacts and locations

1

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Central trial contact

Adam Glass; Jon Silversides

Data sourced from clinicaltrials.gov

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