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ISRCTN
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ISRCTN15027862
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ClinicalTrials.gov identifier
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Public title
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A randomised trial comparing two strategies for preventing kidney failure after angioplasty
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Scientific title
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A randomised factorial trial of N-acetylcysteine prophylaxis and iso-osmolar versus low-osmolar contrast media on kidney function in patients at risk of contrast induced nephropathy following cardiac catheterisation for percutaneous coronary interventions
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Acronym
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CONNECT Trial
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Serial number at source
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805
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Study hypothesis
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1. We hypothesise that N-acetylcysteine antioxidant prophylaxis prevents deterioration of renal impairment and may improve survival
2. We also hypothesise that use of iso-osmolar contrast media prevents deterioration of renal function in patients at high risk of contrast induced nephropathy (CIN)
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Lay summary
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Ethics approval
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Submitted via Integrated Research Application System (IRAS). Approval pending as of 07/05/2009.
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Study design
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Randomised controlled open-label trial with 2 x 2 factorial design
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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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Kidney function impairment/coronary artery disease/ contrast induced nephropathy
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Participants - inclusion criteria
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1. Male and female patients aged 18 years or over
2. Estimated glomerular filtration rate (eGFR) less than 60 ml/m (as calculated by modified Modification of Diet in Renal Disease [MDRD] equation with local laboratory correction factor)
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Participants - exclusion criteria
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1. Patients who had coronary angiography or other procedure with contrast exposure (computed tomography pulmonary angiography [CTPA] etc.) within 2 weeks of percutaneous coronary intervention (PCI)
2. Unable to consent
3. Patient undergoing cardiac surgery
4. Cardiogenic shock
5. Unlikely to attend for follow up blood tests
6. Presence of non cardiac illness that might affect life expectancy
7. Any previous allergic reaction to contrast media or N-acetylcysteine (NAC)
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Anticipated start date
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01/07/2009
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Anticipated end date
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30/06/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200
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Interventions
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All patients undergoing cardiac catheterisation with the intention of percutaneous coronary intervention (definite PCI or catheterisation +/- PCI) that meet the inclusion criteria will be randomised to receive prophylactic N-acetylcysteine or not, with or without iso- and low-osmolar contrast media.
Study arms:
Arm 1: iso-osmolar contrast media
Arm 2: iso-osmolar contrast media + N-acetylcysteine
Arm 3: low-osmolar contrast media
Arm 4: low-osmolar contrast media + N-acetylcysteine
N-acetylcysteine will be given with a loading dose of 1,200 mg orally prior to the procedure on the day followed by 1,200 mg bulk oral dose for a total of 4 times (up to 48 hours) after the procedure.
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Primary outcome measure(s)
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eGFR at 6 months
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Secondary outcome measure(s)
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1. Contrast induced nephropathy. Total duration of follow-up: 6 months.
2. eGFR at 14 days
3. Major Adverse Cardiovascular Events (MACE) – death, myocardial infarction (MI), stroke, and repeat revascularisation. Total duration of follow-up: 6 months.
4. Renal replacement therapy. Total duration of follow-up: 6 months.
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Sources of funding
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1. Liverpool Heart and Chest Hospital (UK) - Internal Charitable Trust
2. Covidien UK Ltd (UK)
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Trial website
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Publications
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Contact name
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Dr
Periaswamy
Vealavan
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Address
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Liverpool Heart and Chest Hospital NHS Trust
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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periaswamy.velavan@lhch.nhs.uk
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Sponsor
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Liverpool Heart and Chest Hospital NHS Trust (UK)
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Address
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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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Sponsor website:
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http://www.lhch.nhs.uk
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Date applied
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07/05/2009
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Last edited
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15/07/2009
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Date ISRCTN assigned
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15/07/2009
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