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ISRCTN
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ISRCTN95530505
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ClinicalTrials.gov identifier
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Public title
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Low or high magnesium concentration in intermittent warm blood cardioplegia in patients undergoing coronary artery surgery: a prospective randomised study
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Scientific title
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Acronym
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N/A
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Serial number at source
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PG/02/044/13713
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Study hypothesis
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A comparison between two diferent strategies of myocardial protection.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled 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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Ischaemic heart disease
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Participants - inclusion criteria
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1. A diagnosis of ischaemic heart disease
2. Undergoing primary myocardial revascularisation with the use of cardiopulmonary bypass and cardioplegic arrest
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/12/2001
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Anticipated end date
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01/12/2004
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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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400 adult patients
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Interventions
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Patients will be randomised to:
1. 5 mmol/l Magnesium (Mg2+)
2. 16 mmol/l Mg2+)
In the intermittent antegrade warm blood cardioplegia
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Primary outcome measure(s)
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Not provided at time of registration
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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 (UK)
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Trial website
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Publications
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Contact name
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Mr
Massimo
Caputo
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Address
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Bristol Heart Institute
Bristol Royal Infirmary
Marlborough Street
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City/town
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Bristol
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Zip/Postcode
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BS2 8HW
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Country
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United Kingdom
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Tel
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+44 (0)117 9283145
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Fax
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+44 (0)117 929737
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Email
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massimocaputo@hotmail.com
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Sponsor
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British Heart Foundation (UK)
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Address
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14 Fitzhardinge Street
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City/town
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London
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Zip/Postcode
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W1H 6DH
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Country
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United Kingdom
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Tel
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+44 (0)20 7935 0185
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Fax
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+44 (0)20 7486 5820
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Email
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research@bhf.org.uk
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Sponsor website:
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http://www.bhf.org.uk/
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Date applied
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23/04/2002
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Last edited
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02/10/2007
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Date ISRCTN assigned
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23/04/2002
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