Contact information
Type
Scientific
Primary contact
Dr Periaswamy Vealavan
ORCID ID
Contact details
Liverpool Heart and Chest Hospital NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
periaswamy.velavan@lhch.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
805
Study information
Scientific title
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
Acronym
CONNECT
Study hypothesis
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)
Ethics approval
Submitted via Integrated Research Application System (IRAS) approval pending as of 07/05/2009
Study design
Randomised controlled open-label trial with 2 x 2 factorial design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Kidney function impairment/coronary artery disease/contrast-induced nephropathy
Intervention
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 four times (up to 48 hours) after the procedure.
Updated 06/08/2014: this trial was stopped before recruitment began in 2011 due to changing practices and procedures, lack of funding and resources and time availability.
Intervention type
Drug
Phase
Not Applicable
Drug names
N-acetylcysteine
Primary outcome measures
eGFR at 6 months
Secondary outcome measures
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.
Overall trial start date
01/07/2009
Overall trial end date
30/06/2011
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
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)
Recruitment start date
01/07/2009
Recruitment end date
30/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool Heart and Chest Hospital NHS Trust
Liverpool
L14 3PE
United Kingdom
Sponsor information
Organisation
Liverpool Heart and Chest Hospital NHS Trust (UK)
Sponsor details
Thomas Drive
Liverpool
L14 3PE
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Liverpool Heart and Chest Hospital (UK) - Internal Charitable Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Covidien UK Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary