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ISRCTN
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ISRCTN33236666
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ClinicalTrials.gov identifier
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Public title
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Contribution of inflammatory mechanisms to myocardial and vascular injury in coronary reperfusion
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Scientific title
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Acronym
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CRF & Endothelial Function
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Serial number at source
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4610
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Study hypothesis
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This is an observational study investigating the role of inflammation in myocardial microvascular injury following coronary angioplasty and stenting.
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Ethics approval
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MREC approved (ref: 05/Q1502/72)
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Study design
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Single centre non-randomised observational 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; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Other
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Participants - inclusion criteria
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1. Undergoing single vessel percutaneous coronary intervention (PCI) in left anterior descending (LAD) or circumflex (Cx) artery
2. Without other signficant coronary disease
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Participants - exclusion criteria
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1. Recent acute coronary syndrome (ACS)
2. Other inflammatory disease
3. Asthma
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Anticipated start date
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01/04/2006
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Anticipated end date
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14/10/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Planned sample size: 50
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Interventions
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Patients undergo measurement of inflammatory markers pre- and post-angioplasty and measurement of microvascular function pre- and post-PCI.
Study entry: registration only
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Primary outcome measure(s)
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Degree of change of microvascular function post-PCI
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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British Heart Foundation (BHF) (UK)
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Trial website
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Publications
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Contact name
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Dr
Dr Billal
Patel
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Address
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The Cardiothoracic Centre
Thomas Drive
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City/town
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Liverpool
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Zip/Postcode
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L14 3PE
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Country
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United Kingdom
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Email
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billalgbd@googlemail.com
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Sponsor
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Royal Liverpool University Hospital (UK)
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Address
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Research & Development, 4th Floor
Linda McCartney Centre
Prescot Street
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City/town
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Liverpool
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Zip/Postcode
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L7 8XP
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Country
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United Kingdom
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Sponsor website:
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http://www.rlbuht.nhs.uk/
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Date applied
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07/07/2010
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Last edited
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07/07/2010
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Date ISRCTN assigned
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07/07/2010
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