Condition category
Urological and Genital Diseases
Date applied
26/08/2011
Date assigned
13/03/2012
Last edited
24/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.randox.com/

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

Publication citations

Additional files

Editorial Notes

24/08/2016: No publications found, verifying study status with principal investigator