[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551837":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":43,"studyPopulation":44,"armGroups":45,"interventions":59,"overallOfficials":39,"centralContacts":69,"locations":78,"responsibleParty":100,"collaborators":39,"id":102,"slug":39,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":39,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":39,"enrollmentInfo":111,"targetDuration":39,"studyType":114,"phases":39,"briefSummary":115,"conditions":116,"keywords":39,"overallStatus":80,"whyStopped":39,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Belfast Health and Social Care Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"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-\u002Finter-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",[14,17,20,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"1) Acceptability of the dobutamine stress CMR protocol to patients, by completion","Assessed by patient recruitment\u002Fwithdrawal rate compared to our previous CMR studies that were performed without dobutamine stress testing.",{"measure":21,"description":22,"timeFrame":12},"2) Incidence of complications related to dobutamine stress CMR","We will assess for the onset of any of the following during the scan\n\n1. New onset atrial fibrillation\n2. Ventricular tachycardia\n3. Angina, chest pain, shortness of breath and\u002For ischaemic ECG changes",{"measure":24,"description":25,"timeFrame":12},"3) Change in RVCreserve change following lung resection","Comparison of the change in RVEF on stress pre- and post-operatively",{"measure":27,"description":28,"timeFrame":12},"4) Change in PVreserve change following lung resection","Comparison of change in wave reflection on stress pre- and post-operatively",{"measure":30,"description":31,"timeFrame":12},"5) Association between the changes in RVCreserve and markers of cardiac inflammation, BNP","Comparison of change in RVCreserve and the change in BNP",{"measure":33,"description":34,"timeFrame":12},"5) Association between the changes in RVCreserve and markers of cardiac inflammation, hsTnT","Comparison of change in RVCreserve and the change in hsTnT.",{"measure":36,"description":37,"timeFrame":38},"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",null,{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":41,"timePerspective":42,"maskingInfo":39},"COHORT","PROSPECTIVE","We hypothesise that following lung resection,\n\n1. 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),\n2. impaired RVCreserve is associated with impaired functional capacity .\n\nIn 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.\n\nAdditionally, 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.","Adult patients presenting for surgical resection of lung, oesophagus or stomach.",[46,52,56],{"label":47,"type":39,"description":48,"interventionNames":49},"Lung resection","12 patients undergoing lobectomy. Pre and post-operative dobutamine stress CMR testing and cardiac biomarker testing.",[50,51],"Diagnostic Test: Dobutamine stress CMR","Diagnostic Test: Cardiac biomarker sample",{"label":53,"type":39,"description":54,"interventionNames":55},"Oesophagectomy","15 patients Peri-operative cardiac biomarker testing.",[51],{"label":57,"type":39,"description":54,"interventionNames":58},"Gastrectomy",[51],[60,65],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":39},"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\u002Fkg\u002Fmin. The patients' medications will be managed in keeping with the usual clinical practice and departmental guidelines.\n\nAt 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.\n\nPost-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.",[47],{"type":61,"name":66,"description":67,"armGroupLabels":68,"otherNames":39},"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",[57,47,53],[70,75],{"name":71,"role":72,"phone":73,"phoneExt":39,"email":74},"Adam Glass","CONTACT","+442890976378","a.glass@qub.ac.uk",{"name":76,"role":72,"phone":39,"phoneExt":39,"email":77},"Jon Silversides","j.silversides@qub.ac.uk",[79],{"facility":5,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"RECRUITING","Belfast","Northern Ireland","BT12 6BA","United Kingdom","UK",{"type":87,"coordinates":88},"Point",[89,90],-5.92541,54.59682,{"lat":90,"lon":89},[93,96,97,99],{"name":76,"role":72,"phone":94,"phoneExt":39,"email":95},"02895041096","jon.silversides@belfasttrust.hscni.net",{"name":71,"role":72,"phone":39,"phoneExt":39,"email":39},{"name":98,"role":72,"phone":39,"phoneExt":39,"email":39},"Danny McAuley",{"name":76,"role":72,"phone":39,"phoneExt":39,"email":39},{"type":101,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100551837",false,"NCT06465277","CMR Right Ventricular Contractile Reserve Following Lung Resection","Assessment of Right Ventricular Contractile Reserve Following Lung Resection by Dobutamine Stress Cardiac Magnetic Resonance: a Feasibility Study","Inclusion Criteria:\n\n* 1\\) Provision of informed consent 2) Age \\>16 years 3) Planned elective\n\n  1. lobectomy lung resection or\n  2. oesophagectomy surgery with one lung ventilation or\n  3. gastrectomy\n\nExclusion Criteria:\n\n1. Pregnancy\n2. On-going participation in any investigational research which could undermine the scientific basis of the study\n3. Atrial fibrillation at baseline\n4. Any contraindication to\n\n   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\u002F120 mmHg) ii. Unstable angina pectoris iii. Severe aortic valve stenosis (peak aortic valve gradient \\>60mmHg or aortic valve area \\\u003C 1cm2) iv. Complex cardiac arrhythmias including uncontrolled atrial fibrillation v. Hypertrophic obstructive cardiomyopathy vi. Myocarditis, endocarditis, or pericarditis vii. Uncontrolled heart failure\n5. Lung resection specific\n\n   1. Wedge, segmental or sub-lobar lung resection\n   2. Pneumonectomy\n   3. Isolated right middle lobectomy\n\n      \\-",true,"ALL","18 Years",{"count":112,"type":113},42,"ESTIMATED","OBSERVATIONAL","Feasibility study investigating CMR dobutamine stress testing before and after lung resection",[117,118,119],"Lung Cancer","Surgery","Anesthesia","2024-10-02",{"date":122,"type":123},"2024-10-03","ACTUAL",{"date":125,"type":123},"2023-07-21",{"date":127,"type":113},"2024-12",{"name":5,"class":6},1]