Plain English Summary
Background and study aims
In Northern Ireland the rising number of patients with both chronic kidney disease (CKD) and heart disease is explained by many risk factors. These include age, high blood pressure, diabetes and obesity. Around 6000 coronary dye tests are performed each year in Northern Ireland. 20% of patients tested will have CKD and are at high risk of kidney damage due to the harmful dye used (contrast-induced nephropathy - CIN). Contrast dye is toxic to the kidney. Unfortunately there is no alternative to it and the number of patients who develop this complication is set to rise.
Acute kidney injury (AKI) is best avoided; once developed it dramatically increases risk of death, length of hospital stay and healthcare costs. Current tests fail to detect early AKI and there is a need for new markers of kidney damage. Neutrophil gelatinase associated lipocalin (NGAL) has the potential to detect AKI within a few hours of onset; we aim to study it in a high-risk CKD population.
This study aims to find out whether NGAL could be a useful marker of early CIN and see if it can predict severity of CIN, and to see if NGAL could be used to identify those at high risk of CIN.
Who can participate?
Patients at high risk of CIN will be identified prior to cardiac catheterisation at Craigavon Area Hospital between October 2011 and August 2013. All patients over the age of 18 with existing chronic renal failure, as shown by abnormal blood tests before the dye test, will be invited to take part. Men and women will both be invited.
What does the study involve?
A fluid drip will be given to help protect kidney function before the dye test. Blood samples will be collected directly before and after the dye test, and at 2, 4, 6, 24 and 48 hour time-points. Additional blood will be stored for possible future testing.
What are the possible benefits and risks of participating?
New markers to detect AKI early would help to treat patients who develop AKI sooner. If realised, this research has the potential to dramatically increase the safety of coronary dye testing and could greatly benefit patients both in Northern Ireland and further afield. The only risk to patients will be that of serial blood sampling, which may cause minor bleeding, pain or bruising. This will be reduced by using the smallest needle possible. All patients will have the same treatment.
Where is the study run from?
Craigavon Area Hospital (UK).
When is the study starting and how long is it expected to run for?
The study will run from October 2011 to August 2013.
Who is funding the study?
RANDOX laboratories.
Who is the main contact?
Dr Michael Connolly
Research Fellow
Cardiac Research
Craigavon Area Hospital
Trial website
Contact information
Type
Scientific
Primary contact
Dr David Mc Eneaney
ORCID ID
Contact details
Cardiology Unit
Craigavon Area Hosptial
68 Lurgan Road
Portadown
BT63 5QQ
United Kingdom
+44 (0)2838 334 444
david.mceneaney@southerntrust.hscni.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.1 19/08/2011
Study information
Scientific title
Neutrophil Gelatinase Associated Lipocalin (NGAL) as a predictor of acute kidney injury post coronary angiogram: a cohort observational study
Acronym
Study hypothesis
Raised levels of NGAL at 4 hours post contrast angiogram will predict acute kidney injury, as evidenced by a rise in creatinine > 25% at 48 hours.
Ethics approval
Not provided at time of registration
Study design
Cohort observational study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic Renal Disease
Intervention
Samples for serum and urine NGAL, serum cystatin C and serum creatinine will be collected directly pre- and post-contrast angiogram, and at 2, 4, 6, 24 and 48 hr time-points to allow time course analysis post catheterisation.
Patients will be followed up at 30 days and 1 year.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Post procedure biomarker elevation diagnostic for acute kidney injury
Secondary outcome measures
Major cardiac adverse events (MACE) at 30 days and one year:
1. Myocardial infarction
2. Stroke
3. Heart failure hospitalisation
4. Death
Overall trial start date
15/10/2011
Overall trial end date
03/08/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age > 18 years
2. Presenting for angiogram with known chronic kidney disease (CKD) [glomerular filtration rate (GFR) < 60mls/min]
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Myocardial infarction (MI) or acute coronary syndrome within previous 6 weeks
2. Hospitalisation within previous 6 weeks
3. Decompensated heart failure
4. Inability to give informed consent
Recruitment start date
15/10/2011
Recruitment end date
03/08/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiology Unit
Portadown
BT63 5QQ
United Kingdom
Sponsor information
Organisation
Randox Laboratories (UK)
Sponsor details
55 Diamond Road
Crumlin
Antrim
BT29 4QY
United Kingdom
+44 (0)2894 422 413
maryjo.kurth@randox.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Randox Laboratories (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