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Clinical Trials/NCT01892800
NCT01892800
Unknown
Not Applicable

The Pulmonary Vascular / Right Ventricular Response to Lung Resection

University of Glasgow1 site in 1 country25 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
University of Glasgow
Enrollment
25
Locations
1
Primary Endpoint
Right ventricular ejection fraction
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is explore the impact of lung cancer surgery on the function of the right side of the heart.

Detailed Description

Lung cancer is the second most common cancer in the UK. In suitable cases the best chance of cure is surgical resection. Studies suggest that lung resection is associated with right ventricular (RV) dysfunction, predisposing to complications and post-operative dyspnoea. Studies of RV function following lung resection have been hampered by the limitations of the techniques used. In addition the mechanism of RV dysfunction has remained elusive. In this prospective observational study the RV response to lung resection will be characterised by sequential assessment of right ventricular ejection fraction (RVEF) measured using cardiovascular magnetic resonance (CMR). CMR is non-invasive, involves no ionising radiation and due to its high spatial resolution is the gold standard for assessing RV volumes. Comprehensive CMR and echocardiographic assessment of the pulmonary vascular - RV axis will allow us to interpret peri-operative changes in RVEF in the context of RV contractility and loading indices. In addition, contemporaneous blood samples will be taken for measurement of biomarkers of myocardial and endothelial dysfunction and systemic inflammation. With increased understanding of the mechanisms involved, it may be possible to prevent RV dysfunction; reducing complication rates, hospital stay and costs and ameliorating long term dyspnoea.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
August 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Ben Shelley

Clinical Research Fellow

University of Glasgow

Eligibility Criteria

Inclusion Criteria

  • Provision of informed consent
  • Age \>16 years
  • Planned elective lung resection by lobectomy

Exclusion Criteria

  • On-going participation in any investigational research which could undermine the scientific basis of the study
  • Contraindications to magnetic resonance imaging:
  • i. Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant ii. Aneurysm clips iii. Metal injuries to the eye iv. Loose metal in an part of the body
  • Wedge / segmental / sub-lobar lung resection
  • Pneumonectomy
  • Isolated right middle lobectomy

Outcomes

Primary Outcomes

Right ventricular ejection fraction

Time Frame: 3 days

The primary objective of this study is determine whether RVEF falls post-operatively in patients undergoing lung resection. The primary outcome is RVEF at 3 days post-lung resection compared to pre-operative values determined by CMR.

Secondary Outcomes

  • Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF(3 days)
  • RVEF vs LVEF(3 days)
  • Association between RVEF and contractility / loading indices(3 days)
  • Association between RVEF and functional status(3 months and 1 year)

Study Sites (1)

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