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ISRCTN
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ISRCTN58128724
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ClinicalTrials.gov identifier
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Public title
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A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement
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Scientific title
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Acronym
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MiniStern Trial
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Serial number at source
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7766
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Study hypothesis
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MiniStern is a pragmatic, prospective randomised controlled trial comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).
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Lay summary
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Ethics approval
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MREC approved (ref: 09/H0301/58)
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Study design
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Single centre randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Surgery
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Participants - inclusion criteria
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1. Aged greater than 18 years at the time of surgery, either sex
2. Elective, first time, isolated aortic valve replacement (AVR)
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Participants - exclusion criteria
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1. Documented poor left ventricular (LV) function or left ventricular ejection fraction (LVEF) 30%
2. Documented chest wall deformities
3. Documented severe emphysema or chronic obstructive pulmonary disease (COPD)
4. Current body mass index (BMI) greater than 35 kg/m^2
5. Concomitant cardiac surgery
6. Redo surgery
7. Median sternotomy indicated
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Anticipated start date
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30/11/2009
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Anticipated end date
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01/09/2012
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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Planned sample size: 240
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Interventions
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Comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).
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Primary outcome measure(s)
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Total length of stay in hospital for the index AVR operation measured in days
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Secondary outcome measure(s)
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1. Fitness for discharge
2. Health related quality of life and patient satisfaction at baseline, 6 weeks, 6 months and 12 months using the 36-item short form health survey (SF-36) and Coronary Revascularization Outcome Questionnaire - Coronary Artery Bypass Graft (CROQ-CABG)
3. Heart function (LVEF) by echocardiography at baseline, day of discharge and 6 months post surgery
4. Procedure time: total theatre time, cross clamp time, cardiopulmonary bypass time, blood loss, blood transfusion
5. Respiratory function (forced expiratory volume in one second [FEV1]) by hand held spirometry at baseline, day 4, day of discharge, 6 weeks and 6 months
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)
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Trial website
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Publications
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Contact name
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Mr
Sukumaran
Nair
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Address
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Papworth Hospital NHS Foundation Trust
Papworth Everard
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City/town
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Cambridge
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Zip/Postcode
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CB23 3RE
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Country
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United Kingdom
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Sponsor
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Papworth Hospital NHS Foundation Trust (UK)
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Address
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Papworth Everard
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City/town
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Cambridge
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Sponsor website:
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http://www.papworthhospital.nhs.uk/index.php
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Date applied
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24/06/2010
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Last edited
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24/06/2010
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Date ISRCTN assigned
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24/06/2010
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